Generated by All in One SEO v4.9.10, this is an llms.txt file, used by LLMs to index the site. # EUCOPE AISBL European Confederation of Pharmaceutical Entrepreneurs AISBL ## Sitemaps - [XML Sitemap](https://www.eucope.org/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [News](https://www.eucope.org/news/) - [EUCOPE signs Joint Statement on opt-out requirements in EHDS](https://www.eucope.org/eucope-signs-joint-statement-on-opt-out-requirements-in-ehds/) - In June 2023, we signed a joint statement with a large group of European stakeholders for our recommendations for an effective opt-out mechanism. - [EUCOPE strengthens its expertise on Joint Clinical Assessments with the appointment of Dr. Thomas Ecker](https://www.eucope.org/eucope-strengthens-its-expertise-on-joint-clinical-assessments-with-the-appointment-of-dr-thomas-ecker/) - EUCOPE strengthens its expertise on Join Clinical Assessments and EU HTA with the appointment of Dr. Thomas Ecker as Senior Expert. - [EUCOPE welcomes Diego Ardigò as new Chair of the Board](https://www.eucope.org/eucope-welcomes-diego-ardigo-as-new-chair-of-the-board/) - EUCOPE welcomes Diego Ardigò as new Chair of the EUCOPE Board. Alexander Natz thanks outgoing Chair Jan G. Smith and welcomes Diego Ardigò. Contact: Matthias Heck - [EUCOPE on First Joint Clinical Assessment (JCA) Report: Critical Milestone - Readiness for Orphan Drug Assessments Needed](https://www.eucope.org/eucope-on-first-joint-clinical-assessment-jca-report-critical-milestone-readiness-for-orphan-drug-assessments-needed/) - Brussels 9 June 2026 The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) takes note of today’s publication of the first Joint Clinical Assessment (JCA) report. This marks a critical milestone in the implementation of the Regulation (EU) 2021/2282 on health technology assessment. Over the coming 18 months, full attention must be directed towards ensuring the readiness - [EUCOPE concerns on the provisional trilogue agreement of EU Institutions on the Critical Medicines Act (CMA)](https://www.eucope.org/eucope-concerns-on-the-provisional-trilogue-agreement-of-eu-institutions-on-the-critical-medicines-act-cma/) - Brussels, 12 May 2026 The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing mostly small- to mid-sized innovative pharmaceutical companies in the EU, takes note of today’s provisional trilogue agreement on the Critical Medicines Act (CMA), reached by the EU Institutions. EUCOPE views this agreement as an important opportunity to strengthen the EU’s resilience in the - [EUCOPE reacts to the vote on the provisional agreement on the EU General Pharmaceutical Legislation (GPL)](https://www.eucope.org/eucope-reacts-to-the-vote-on-the-provisional-agreement-on-the-eu-general-pharmaceutical-legislation-gpl/) - EUCOPE reacts to vote in European Parliament's Health Committee (SANT) on the General Pharma Legislation. Overall, mixed signal for the Life Sciences ecosystem. - [European Parliament adopts the Critical Medicines Act: EUCOPE warns against unintended consequences on innovation](https://www.eucope.org/european-parliament-adopts-the-critical-medicines-act-eucope-warns-against-unintended-consequences-on-innovation/) - Brussels, 20 January 2026 – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges today’s adoption of the Critical Medicines Act (CMA) by the European Parliament, which upholds the approach set out in the Public Health Committee (SANT) report endorsed in December 2025. EUCOPE reiterates the opportunities and concerns previously highlighted during the SANT Committee vote. - [New study highlights contribution of €98 billion by the small to mid-sized biopharmaceutical industry as represented by EUCOPE to the EU economy and growing exposure to global policy uncertainty](https://www.eucope.org/new-study-highlights-contribution-of-e98-billion-by-the-small-to-mid-sized-biopharmaceutical-industry-as-represented-by-eucope-to-the-eu-economy-and-growing-exposure-to-global-policy-uncertainty/) - New study highlights contribution of €98 billion by the EUCOPE member companies to the EU economy and growing exposure to global policy uncertainty incl. MFN. - [The EU Raises Its Biotech Ambition — EUCOPE Welcomes the Act’s Strategic Direction](https://www.eucope.org/the-eu-raises-its-biotech-ambition-eucope-welcomes-the-acts-strategic-direction/) - Brussels, 17 December 2025 – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) recognises the publication of the European Biotech Act Part I, as a promising initiative. This Act acknowledges biotechnology and biomanufacturing as strategic pillars for the EU’s competitiveness, health resilience and scientific leadership. EUCOPE strongly supports the political commitment of the Commission’s proposals to - [EUCOPE response to the SANT report on the Critical Medicines Act](https://www.eucope.org/eucope-response-to-the-sant-report-on-the-critical-medicines-act/) - EUCOPE response to the SANT report on the Critical Medicines Act. The text diverges from the CMA’s original purpose: addressing shortages of critical medicines. - [EUCOPE statement on the political agreement on the EU General Pharmaceutical Legislation](https://www.eucope.org/eucope-statement-on-the-political-agreement-on-the-eu-general-pharmaceutical-legislation/) - The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) acknowledges the provisional political agreement reached on the EU General Pharmaceutical Legislation (GPL) and recognises the efforts of the EU Institutions to modernise the pharmaceutical framework for the first time in over 20 years. This revision will have a significant impact on the innovative pharmaceutical sector, especially on - [EUCOPE: Council position on the Critical Medicines Act brings improvement - but further work is needed](https://www.eucope.org/eucope-council-position-on-the-critical-medicines-act-brings-improvement-but-further-work-is-needed/) - On 2 December 2025, EU Ministers of Health in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) formally adopted its General Approach on the Critical Medicines Act (CMA). EUCOPE appreciates the clear distinction between measures applying to critical medicines and to medicinal products of common interest (MPCI). These categories face different challenges and - [EUCOPE Publishes White Paper on Strengthening ATMP Manufacturing in Europe](https://www.eucope.org/eucope-publishes-white-paper-on-strengthening-atmp-manufacturing-in-europe/) - EUCOPE White Paper on ATMP Manufacturing in the EU - 5 challenge areas and 23 policy recommendations for a competitive and innnovation-friendly ATMP ecosystem - [SOUNDS OF SCIENCE PODCAST EPISODE #23 – Impact of EU legislations on the competitiveness of the life sciences sector](https://www.eucope.org/sounds-of-science-podcast-episode-23-impact-of-eu-legislations-on-the-competitiveness-of-the-life-sciences-sector/) - Sounds of Science – Episode 23 Competitiveness in Life Sciences: Report on Impact of EU Legislations In this episode of EUCOPE Sounds of Science, we launch the report titled Competitiveness of the EU Life Sciences Sector – Analysis of the impact of current and future EU legislations on the competitiveness of the EU life sciences sector. This - [EUCOPE and Copenhagen Economics Publish New Report on the impact of EU Legislations on Life Sciences Competitiveness](https://www.eucope.org/eucope-and-copenhagen-economics-publish-new-report-on-the-impact-of-eu-legislations-on-life-sciences-competitiveness/) - Press Release Brussels, 17 November 2025 Today, the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) published a new report titled Competitiveness of the EU Life Sciences Sector – Analysis of the impact of current and future EU legislations on the competitiveness of the EU life sciences sector, developed in collaboration with Copenhagen Economics. The report examines - [EU Medical Countermeasures and Stockpiling Strategies: critical steps toward stronger health emergency preparedness](https://www.eucope.org/eu-medical-countermeasures-and-stockpiling-strategies-critical-steps-toward-stronger-health-emergency-preparedness/) - Brussels, 9 July 2025 – The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) reckons both the EU Medical Countermeasures and Stockpiling Strategies, published today, as positive steps toward improving the EU’s preparedness for future health emergencies. In an increasingly uncertain geopolitical scenario, strengthening the EU medical countermeasures (MCMs) framework is essential to coordinate the availability of - [EU Life Sciences Strategy: a step towards a stronger, innovation-friendly ecosystem](https://www.eucope.org/eu-life-sciences-strategy-a-step-towards-a-stronger-innovation-friendly-ecosystem/) - EUCOPE supports the European Commission’s ambition to strengthen the EU’s healthcare ecosystem through a comprehensive EU Life Sciences Strategy. - [SOUNDS OF SCIENCE PODCAST EPISODE #22 – Tackling Antimicrobial Resistance: EUCOPE’s Position and Industry Perspectives](https://www.eucope.org/sounds-of-science-podcast-episode-22-tackling-antimicrobial-resistance-eucopes-position-and-industry-perspectives/) - This new episode of Sounds of Science, the EUCOPE podcast, takes a deep dive into one of today’s most pressing health threats: antimicrobial resistance (AMR). - [EUCOPE Member Spotlight: Q&A with Jane Cooper Senior Vice President and Region Head for Ultragenyx Europe, Middle East and Africa](https://www.eucope.org/eucope-member-spotlight-qa-with-jane-cooper-senior-vice-president-and-region-head-for-ultragenyx-europe-middle-east-and-africa/) - For the June edition of the EUCOPE Member Spotlight, we spoke with Jane Cooper Senior Vice President & Region Head for Ultragenyx Europe, Middle East and Africa - [EUCOPE Response to Council Agreement on Pharma Package: Innovation must remain a priority](https://www.eucope.org/eucope-response-to-council-agreement-on-pharma-package-innovation-must-remain-a-priority/) - EUCOPE acknowledges the step forward in the legislative process and urges EU policymakers to safeguard the EU’s innovation-driven life sciences ecosystem. - [SOUNDS OF SCIENCE PODCAST EPISODE #21 – EU Biotech Act: How to ensure the biopharmaceutical sector thrives in the EU](https://www.eucope.org/sounds-of-science-podcast-episode-21-eu-biotech-act-how-to-ensure-the-biopharmaceutical-sector-thrives-in-the-eu/) - In episode 21, Sounds of Science explores expectations for the future of the biopharmaceutical sector and shares key recommendations for strengthening it. - [Joint EUCOPE - IFPMA statement to support the adoption of the WHA Resolution on Rare Diseases](https://www.eucope.org/joint-eucope-ifpma-statement-to-support-the-adoption-of-the-wha-resolution-on-rare-diseases/) - On 16 April 2025, IFPMA and EUCOPE published a joint statement supporting the adoption of the World Health Assembly Resolution on Rare Diseases. - [EUCOPE Member Spotlight: Q&A with Muriel O’Byrne Senior Vice President and Head of International Regulatory Affairs and the European Business Office at Regeneron](https://www.eucope.org/eucope-member-spotlight-qa-with-muriel-obyrne-senior-vice-president-and-head-of-international-regulatory-affairs-and-the-european-business-office-at-regeneron/) - For the EUCOPE Member Spotlight, we spoke with Muriel O’Byrne Senior VP and Head of International Reg. Affairs and the European Business Office at Regeneron - [EUCOPE Member Spotlight: Q&A with Corinne Schmitz - Chairman, Founder & CEO at Azurbio Pharma](https://www.eucope.org/eucope-member-spotlight-qa-with-corinne-schmitz-chairman-founder-ceo-at-azurbio-pharma/) - For the April edition of the EUCOPE Member Spotlight, we spoke with Corinne Schmitz - Chairman, Founder & CEO at Azurbio Pharma - [EUCOPE statement on the European Commission’s Strategic Dialogue with the pharmaceutical sector and the potential of tariffs](https://www.eucope.org/eucope-statement-on-the-european-commissions-strategic-dialogue-with-the-pharmaceutical-sector-and-the-potential-of-tariffs/) - EUCOPE issued a press release on the European Commission's strategic dialogue with the pharmaceutical sector and the potential of tariffs. - [Health Stakeholders advocate for enhanced collaboration in European Health Data Space (EHDS) Implementation](https://www.eucope.org/health-stakeholders-advocate-for-enhanced-collaboration-in-european-health-data-space-ehds-implementation/) - EUCOPE signs a joint statement welcoming the publication of the EHDS regulation in the EU OJ and calling for a Stakeholder Forum for an effective implementation - [EUCOPE’s Sounds of Science Podcast – Episode #20 Tackling Medicine Shortages: The Role of EU Policies](https://www.eucope.org/eucopes-sounds-of-science-podcast-episode-20-tackling-medicine-shortages-the-role-of-eu-policies/) - In this episode of Sounds of Science, Sean Byrne and Stefano Romanelli discuss the role of EU policies in tackling medicine shortages. - [EUCOPE Member Spotlight: Q&A with Sarah Boyce, President and Chief Executive Officer at Avidity Biosciences](https://www.eucope.org/eucope-member-spotlight-qa-with-sarah-boyce-president-and-chief-executive-officer-at-avidity-biosciences/) - For the February edition of the EUCOPE Member Spotlight, we spoke with Sarah Boyce, President and Chief Executive Officer at Avidity Biosciences - [EUCOPE’s Sounds of Science Podcast – Episode #19 Building a competitive pharmaceutical ecosystem: EUCOPE’s call to EU Institutions](https://www.eucope.org/eucopes-sounds-of-science-podcast-episode-19-building-a-competitive-pharmaceutical-ecosystem-eucopes-call-to-eu-institutions/) - In episode 19, Sounds of Science discusses the importance of creating a sound and robust ecosystem for the pharmaceutical sector to boost innovation. - [EUCOPE Member Spotlight: Q&A with Antoine Bernasconi, Executive VP, Chief Commercial Officer Europe & International at SERB Pharmaceuticals](https://www.eucope.org/eucope-member-spotlight-qa-with-antoine-bernasconi-executive-vp-chief-commercial-officer-europe-international-at-serb-pharmaceuticals/) - For the January edition of the EUCOPE Member Spotlight, we spoke with Antoine Bernasconi, Executive VP, Chief Commercial Officer Europe & International at SERB. - [EUCOPE Member Spotlight: Q&A with Catherine Owen Adams, CEO of Acadia Pharmaceuticals](https://www.eucope.org/eucope-member-spotlight-qa-with-catherine-owen-adams-ceo-of-acadia-pharmaceuticals/) - For the November edition of the EUCOPE Member Spotlight, we spoke with Catherine Owen Adams, CEO of Acadia Pharmaceuticals. - [EVENT RECAP - What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package?](https://www.eucope.org/event-recap-what-drives-life-sciences-investment-in-the-eu-and-the-future-impact-of-the-pharma-package/) - Read the recap of event launching the report: ‘’The Economic Lens: Understanding What Makes the EU Attractive for Life Sciences Investments’’. - [Pharmaceutical innovators are concerned over not enough advice meetings being offered in 2025 for discussing trial designs and evidence generation plans, with serious ramifications on the ability to undergo Joint Clinical Assessments](https://www.eucope.org/pharmaceutical-innovators-are-concerned-over-not-enough-advice-meetings-being-offered-in-2025-for-discussing-trial-designs-and-evidence-generation-plans-with-serious-ramifications-on-the-ability-to-u/) - ARM, EFPIA, EUCOPE, EuropaBio, and Vaccines Europe issued a joint statement following the publication of the 2025 work programme of the HTA Coordination Group. - [A New Drive For Competitiveness - EUCOPE Welcomes New European Commissioners](https://www.eucope.org/a-new-drive-for-competitiveness-eucope-welcomes-new-european-commissioners/) - EUCOPE congratulates the appointed European Commissioners. Their leadership is essential to drive necessary advancements for the pharmaceutical ecosystem. - [EUCOPE Member Spotlight: Q&A with Bristol Myers Squibb](https://www.eucope.org/eucope-member-spotlight-qa-with-bristol-myers-squibb/) - For the November edition of the EUCOPE Member Spotlight, we spoke with Adam Parnaby, Senior Director, Market Access Policy, Europe, Bristol Myers Squibb. - [EUCOPE and FTI Consulting EU Unveil New Report on Life Sciences Investment in the EU](https://www.eucope.org/eucope-and-fti-consulting-unveil-new-report-on-life-sciences-investment-in-the-eu/) - EUCOPE and FTI Consulting EU published a comprehensive report: The Economic Lens: Understanding What Makes the EU Attractive for Life Sciences Investments. - [Building a Competitive and Attractive Pharmaceutical Ecosystem in the EU](https://www.eucope.org/building-a-competitive-and-attractive-pharmaceutical-ecosystem-in-the-eu/) - EUCOPE issued a high level letter calling on EU Institutions and Member States to build a competitive and attractive pharmaceutical ecosystem for innovation. - [2 new members join EUCOPE network in October 2024](https://www.eucope.org/2-new-members-join-eucope-network-in-october-2024/) - EUCOPE announced 2 new members in October 2024: Avidity Biosciences and Decisive Consulting. - [Fostering a European Advanced Diagnostics Ecosystem](https://www.eucope.org/fostering-a-european-advanced-diagnostics-ecosystem/) - The Advanced Diagnostics Working Group is gathers diagnostics companies to ensure Europe draws benefit from the significant advances made in genomic testing. - [EVENT RECAP - Life Science Lectures - Episode eight – “The European Health Data Space (EHDS): your journey from regulation to implementation’’](https://www.eucope.org/event-recap-life-science-lectures-episode-eight-the-european-health-data-space-ehds-your-journey-from-regulation-to-implementation/) - EUCOPE hosted the eighth episode of its Life Science Lectures on the the EHDS legislative text, its implementation and challenges for pharmaceutical companies. - [EUCOPE Member Spotlight: Q&A with EVERSANA](https://www.eucope.org/eucope-member-spotlight-qa-with-eversana/) - M. Ryan, EVERSANA General Manager Europe discuss the challenges facing the life sciences in Europe and how to help manufacturers better understand EU major heath policies - [EUCOPE Member Spotlight: Q&A with Chiesi GRD](https://www.eucope.org/eucope-member-spotlight-qa-with-chiesi-global-rare-diseases/) - Chiesi GRD discuss their collaborative approach with the patients’ community and what’s needed to support the delivery of innovation for rare diseases in EU - [EUCOPE congratulates Ursula von der Leyen on her second mandate as President of the European Commission](https://www.eucope.org/eucope-congratulates-ursula-von-der-leyen-on-her-second-mandate-as-president-of-the-european-commission/) - EUCOPE congratulates Ursula von der Leyen on the confirmation of her second term as President of the European Commission. Her leadership and commitment to public health have been instrumental in steering Europe through challenging times. It is now fundamental to build on these accomplishments, delivering on the European Health Union, and encouraging further innovation in - [7 new members join EUCOPE network in June 2024](https://www.eucope.org/7-new-members-join-eucope-network-in-june-2024/) - EUCOPE announced 7 new members in June 2024: Acadia, Edelman Global Advisory, Elevate Bio, GE Healthcare, Regeneron, Rhythm , SERB Pharmaceuticals - [EUCOPE commends the Council Conclusions on the Future of the European Health Union, supporting a strong environment for pharmaceutical innovation](https://www.eucope.org/eucope-commends-the-council-conclusions-on-the-future-of-the-european-health-union-supporting-a-strong-environment-for-pharmaceutical-innovation/) - EUCOPE is pleased that health remains a focus area for Member States at EU level, as part of EPSCO Conclusions on the Future of the European Health Union - [EUCOPE Congratulates Newly Elected MEPs, Looks Forward to Collaborative Efforts in Advancing a Globally Competitive EU Healthcare Ecosystem](https://www.eucope.org/eucope-congratulates-newly-elected-meps-looks-forward-to-collaborative-efforts-in-advancing-a-globally-competitive-eu-healthcare-ecosystem/) - EUCOPE Congratulates Newly Elected MEPs, Looks Forward to Collaborative Efforts in Advancing a Globally Competitive EU Healthcare Ecosystem - [European Parliament formally adopts the European Health Data Space (EHDS) Regulation](https://www.eucope.org/european-parliament-formally-adopts-the-european-health-data-space-ehds-regulation/) - The European Parliament adopted the European Health Data Space Regulation. The EHDS will be crucial for development of innovative and personalised medicines. - [EU Regulation on Substances of Human Origin officially adopted](https://www.eucope.org/eu-regulation-on-substances-of-human-origin-officially-adopted/) - EU Institutions officially adopted Substances of Human Origin (SoHO) Regulation, improving safety and quality of blood, tissues and cells used in healthcare - [European Stakeholders call on the EU to deliver on the ambitions of Europe’s Beating Cancer Plan by increasing access to genomic testing](https://www.eucope.org/european-stakeholders-call-on-the-eu-to-deliver-on-the-ambitions-of-europes-beating-cancer-plan-by-increasing-access-to-genomic-testing/) - The EU must act to ensure suitable access to advanced diagnostics to patients and issue clear guidance to Member States to support wider genomic testing uptake - [EUCOPE signs EURORDIS Open Letter #ActRare2024 at ECRD 2024](https://www.eucope.org/eucope-signs-eurordis-open-letter-actrare2024-at-ecrd-2024/) - EUCOPE sign EURORDIS Open Letterto the European Commission and next European leaders, to shape goal-driven rare disease policies of the future - [Sounds of Science Podcast #18 on the Revision of the General Pharmaceutical Legislation](https://www.eucope.org/sounds-of-science-podcast-18-on-the-revision-of-the-general-pharmaceutical-legislation/) - In this episode of Sounds of Science, we explore the Revision of the General Pharmaceutical Legislation, focusing on the incentive and regulatory frameworks. - [EUCOPE signs the Joint Industry Statement on the European Commission's Initiative "Boosting Biotechnology and Biomanufacturing in the EU"](https://www.eucope.org/eucope-signs-the-joint-industry-statement-on-the-european-commissions-initiative-boosting-biotechnology-and-biomanufacturing-in-the-eu/) - EUCOPE signed a Joint Statement on the Initiative "Boosting Biotechnology and Biomanufacturing in the EU", with industry associations representing biotech. - [EUCOPE appointed to the new Critical Medicines Alliance](https://www.eucope.org/eucope-appointed-to-the-new-critical-medicines-alliance/) - EUCOPE officially announced as a member of the Critical Medicines Alliance and as one of the industry representatives in the Steering Board of the Alliance. - [EUCOPE launches the European Coalition for Access to Comprehensive Genomic Profiling (ECGP)](https://www.eucope.org/eucope-launches-the-european-coalition-for-access-to-comprehensive-genomic-profiling-ecgp/) - EUCOPE alongside leading diagnostics companies join forces to establish the European Coalition for Access to Comprehensive Genomic Profiling (ECGP) - [European Parliament adopts reports on the Revision of the EU General Pharmaceutical Legislation](https://www.eucope.org/european-parliament-adopts-reports-on-the-revision-of-the-eu-general-pharmaceutical-legislation/) - The European Parliament adopts reports on the Revision of the EU General Pharmaceutical Legislation, recognising the need for a robust incentive framework - [Life science industry concerns over the workability of EU HTA: Europe cannot miss out on the opportunity to speed up access to innovative medicines for European patients](https://www.eucope.org/life-science-industry-concerns-over-the-workability-of-eu-hta-europe-cannot-miss-out-on-the-opportunity-to-speed-up-access-to-innovative-medicines-for-european-patients/) - Life science industry concerns over workability of EU HTA: Europe cannot miss out on the opportunity to speed up access to innovative medicines for patients - [European Parliament’s ENVI committee adopts reports on the EU Pharmaceutical Package](https://www.eucope.org/european-parliaments-envi-committee-adopts-reports-on-the-eu-pharmaceutical-package/) - ENVI adopts reports on EU Pharmaceutical Package. A strong and predictable incentive framework is crucial to ensure EU competitiveness for small biotech. - [EUCOPE welcomes the European Commission’s Communication on boosting biotechnology and biomanufacturing in the EU](https://www.eucope.org/eucope-welcomes-the-european-commissions-communication-on-boosting-biotechnology-and-biomanufacturing-in-the-eu/) - EUCOPE welcomes the Commission's Communication on boosting biotechnology and biomanufacturing in the EU, recognising the important role of health biotech. - [EU Institutions reach a deal on the European Health Data Space (EHDS)](https://www.eucope.org/eu-institutions-reach-a-deal-on-the-european-health-data-space-ehds/) - EU Institutions reached a provisional agreement on the EHDS, securing better healthcare by giving citizens control over their health data and opening for R&D. - [The draft text of the European Health Data Space in trilogues sparks deep concerns in the European healthcare ecosystem](https://www.eucope.org/the-draft-text-of-the-european-health-data-space-ehds-in-trilogues-sparks-deep-concerns-in-the-european-healthcare-ecosystem/) - EUCOPE as part of a coalition of 35 large health stakeholder organisations representing patients, health professionals, researchers and industrial actors in the healthcare ecosystem at both European Union (EU) and Member State level, is expressing its shared concerns about the latest negotiations on the proposed Regulation on the European Health Data Space (EHDS). The EHDS - [The European Health Data Space: concerns and opportunities following ongoing trilogues](https://www.eucope.org/the-european-health-data-space-challenges-and-opportunities-with-respect-to-the-different-proposals-currently-subject-to-the-trilogue-negotiations/) - EUCOPE's Position Determined to make this Europe’s ‘‘Digital Decade’’, the European Commission’s key priority with the proposal of the European Health Data Space (EHDS) is to promote the digital transformation of Europe’s health sector and improve EU healthcare systems. EUCOPE continues to support the creation of the EHDS for purposes such as research, innovation, patient - [EVENT RECAP – Life Science Lectures: Episode Four "Leveraging early advice opportunities in EU HTA"](https://www.eucope.org/event-recap-life-science-lectures-episode-four-leveraging-early-advice-opportunities-in-eu-hta/) - On 14 December, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, hosted the fourth episode of its #LifeScienceLectures webinar series. The focus of the webinar, titled "Leveraging early advice opportunities in EU HTA" was to discuss how best to navigate early advice opportunities with the new EU health technology assessment (HTA), which will be mandatory for - [EVENT RECAP - Life Science Lectures: Episode Three "‘’EU HTA: How will the revised Pharma Package impact the value assessment of therapies?’’](https://www.eucope.org/event-recap-life-science-lectures-episode-three-eu-hta-how-will-the-revised-pharma-package-impact-the-value-assessment-of-therapies/) - On 7 September, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs, hosted the third episode of its #LifeScienceLectures webinar series. The focus of the webinar, titled ‘’EU HTA: How will the revised Pharma Package impact the value assessment of therapies?’’ was to shed light on the interactions between the Regulation (EU) 2021/2282 on Health Technology Assessment - [EUCOPE Member Spotlight: Q&A with Blueprint Medicines](https://www.eucope.org/eucope-member-spotlight-qa-with-blueprint-medicines/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In November, we spoke with Kenneth Saké - Vice President of International Medical Affairs, Blueprint Medicines. Tell us about your organisation and its mission and how you drive innovation - [Stakeholder coalition calls for legislative refinement of the EHDS](https://www.eucope.org/stakeholder-coalition-calls-for-legislative-refinement-of-the-ehds/) - In December 2023, EUCOPE signed a joint statement with a large group of European stakeholders on the significant shortcomings and uncertainties in the EHDS - [9 new members join EUCOPE network in October 2023](https://www.eucope.org/9-new-members-join-eucope-network-in-october-2023/) - EUCOPE was proud to announce the addition of XXX members on during its Board Meeting. These companies will help continue to drive EUCOPE's mission in Europe. - [Six new members join the EUCOPE network in June 2023](https://www.eucope.org/six-new-members-join-the-eucope-network-in-june-2023/) - The European Confederation of Pharmaceuticals Entrepreneurs (EUCOPE) announced the joining of six (6) new members at its quarterly Members Meeting on June 21st, 2023 following Board approval. The new members joining EUCOPE network are Azafaros, Deciphera Pharmaceuticals, Dyne Therapeutics, HemaNext, MediWound and Rocket Pharmaceuticals. During the announcement, EUCOPE’s Secretary General Alexander Natz said, “We’re excited to welcome these - [EUCOPE Member Spotlight: Q&A with Deciphera](https://www.eucope.org/eucope-member-spotlight-qa-with-deciphera/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In October, we spoke with Margarida Duarte, Senior Vice President, Head of International, Deciphera Pharmaceuticals. Margarida Duarte is Senior Vice President, Head of International at Deciphera Pharmaceuticals. Ms. Duarte - [EUCOPE Member Spotlight: Q&A with SKC Consulting](https://www.eucope.org/eucope-member-spotlight-qa-with-skc-consulting/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In September, we spoke with Heike Kielhorn, Managing Partner from SKC. Heike Kielhorn-Schönermark studied business administration and economics in Bayreuth. After graduation she entered the field of economic auditing and - [European Parliament adopts substances of human origin (SoHO) text](https://www.eucope.org/european-parliament-adopts-substances-of-human-origin-soho-text/) - On 12 September 2023, the European Parliament adopted the report on new rules governing the use of so-called substances of human origin (SoHO) intended for human application. The Council still needs to adopt its official position, with the Spanish Presidency hoping to kick off Trilogues by the end of its mandate in December 2023. The - [EUCOPE Member Spotlight: Q&A with Cevidra](https://www.eucope.org/eucope-member-spotlight-qa-with-cevidra/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In September, we spoke with Francois Lontrade, Directeur General, Laboratoire Cevidra. Before joining Cevidra, Francois Lontrade gained 18 years’ experience within the Thea Group, where he contributed to deliver - [EUCOPE attends meeting to discuss opt-out requirements in EHDS](https://www.eucope.org/eucope-attends-meeting-to-discuss-opt-out-requirements-in-ehds/) - EUCOPE, as part of a multi-stakeholder group, met EU officials to discuss how the EHDS can facilitate health research to create tangible benefits for patients. - [EUCOPE Member Spotlight: Q&A with Dyne Therapeutics](https://www.eucope.org/eucope-member-spotlight-qa-with-dyne-therapeutics/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [?️Sounds of Science Podcast #17 on Real-World Evidence (RWE)](https://www.eucope.org/sounds-of-science-podcast-17-on-real-world-evidence-rwe/) - EUCOPE's Sounds of Science Podcast – Episode 17 Real-World Evidence (RWE): The need for a multi-stakeholder approach Within the EU, the life sciences industry requires a strong innovation framework across the patient journey so that such technological advancements can be used to the benefit of all stakeholders. Clinical studies have and always will be the - [EUCOPE's first reflections on the adoption of amended report regulating substances of human origin (SoHO)](https://www.eucope.org/eucopes-first-reflections-on-the-adoption-of-amended-report-regulating-substances-of-human-origin-soho/) - On 18 July, European lawmakers within the Health and Environment (ENVI) committee voted to adopt the amended report on Substances of Human Origin (SoHo). The report aims to improve the safety and quality standards for both donors and recipients of blood, plasma, skin, embryo, sperm, and corneas, with the recent inclusion of breast milk and - [EVENT RECAP - Life Science Lectures: Episode Two "Defining (High) Unmet Medical Need (HUMN)](https://www.eucope.org/event-recap-life-science-lectures-episode-two-defining-high-unmet-medical-need-humn/) - On 7 July, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs – hosted the second episode of its Life Science Lectures webinar series. The focus of the webinar, titled ‘’Defining (high) unmet medical need: will it steer innovation towards filling existing gaps?’’, was to dive deeper into the concepts of unmet medical need (UMN) and - [EVENT RECAP - Life Science Lectures: Episode One "Attaching Conditionalities to Incentives"](https://www.eucope.org/event-recap-life-science-lectures-episode-one/) - On 30 May 2023, EUCOPE hosted the inaugural episode of its Life Science Lectures webinar series, “Attaching conditionalities to incentives: the right path to improve access?” - [EUCOPE releases a White Paper on EU-wide Stockpiling](https://www.eucope.org/eucope-releases-a-white-paper-on-eu-wide-stockpiling/) - On 12 July 2023, EUCOPE's HERA Steering Group released its White Paper "EU-wide Stockpiling: Better Preparedness for Cross-Border Health Threats." Stockpiling of critical biomedical countermeasures is crucial for an effective EU preparedness against priority cross-border health threats with a potentially large health and societal impact. In EUCOPE's view, stockpiling of biomedical countermeasures is important, especially - [Sounds of Science Podcast #16 on OMP Revision's effects on rare disease companies](https://www.eucope.org/sounds-of-science-podcast-16-on-omp-revisions-effects-on-rare-disease-companies/) - EUCOPE'S Sounds of Science Podcast – Episode 16 Rare Reflections: Impact of the OMP revision on rare disease companies in Europe On 26 April 2023, the European Commission published its long awaited proposal revising the foundational pharmaceutical legislation, including the Orphan Medicinal Products (OMP) Regulation. The OMP Regulation has proven to be a successful legislative - [EUCOPE Member Spotlight: Q&A with Hogan Lovells Life Sciences](https://www.eucope.org/eucope-member-spotlight-qa-with-hogan-lovells-life-sciences/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [EUCOPE Member Spotlight: Q&A with Beigene](https://www.eucope.org/eucope-member-spotlight-qa-with-beigene/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [WHO announces end of the COVID-19 public health emergency](https://www.eucope.org/end-of-covid19-emergency/) - On Friday, 5 May, the WHO Director General declared an end to the Public Health Emergency for COVID-19. - [EUCOPE appointed to the new HTA Stakeholder Network](https://www.eucope.org/eucope-appointed-to-the-new-hta-stakeholder-network/) - On 4 May 2023, EUCOPE was announced as a member of the Health Technology Assessment (HTA) Stakeholder Network. The Network has been established to facilitate contributions by a wide range of stakeholders to policy development related to HTAs in the European Union (EU). Since its inception, EUCOPE has firmly advocated for a European HTA that is built - [EUCOPE signs joint letter warning of potential conflicts between Data Act and GDPR](https://www.eucope.org/eucope-signs-joint-letter-warning-of-potential-conflicts-between-data-act-and-gdpr/) - EUCOPE joined an industry coalition to warn of the potential conflicts between the Data Act and GDPR, emphasising importance of ensuring a fair playing field. - [European Commission proposes EU-wide override of patents in emergencies ](https://www.eucope.org/european-commission-proposes-eu-wide-override-of-patents-in-emergencies/) - In legislation , the Commission has proposed introducing a pan-EU compulsory license that could apply to products such as essential drugs in a future pandemic. - [EUCOPE’s statement on the Commission’s proposal for the EU Pharmaceutical Package](https://www.eucope.org/eucopes-statement-on-the-commissions-proposal-for-the-eu-pharmaceutical-package/) - On the Commission's proposal for the EU Pharmaceutical Package On 26 April, the European Commission published the EU Pharmaceutical Package, revising how the pharmaceutical system is regulated in the EU, which includes a proposal for a “master” Regulation, merging Commission Regulation No 726/2004, Orphan Medicinal Products (OMP) Regulation No 141/2000 and Paediatric Regulation No 1901/2006, - [Suspension in assessment of botanical health claims violates EU rule of law](https://www.eucope.org/suspension-in-assessment-of-botanical-health-claims-violates-eu-rule-of-law/) - Art. 28 para. 5 HCR is no longer applicable due to an unlawful act of suspension by the European Commission - [Launch of EUCOPE's Life Science Lectures: Webinar Series](https://www.eucope.org/eucopes-life-science-lectures-webinar-series/) - A multi-stakeholder webinar series focusing on aspects of the EU Pharma Package that are crucial to sustaining a competitive pharmaceutical ecosystem in Europe. - [?️Sounds of Science Podcast #15 on MDR/IVDR Amendments](https://www.eucope.org/sounds-of-science-15-mdr-ivdr-amendments/) - This episode focuses on the recent MDR/IVDR amendments and how they will affect EU medical device and companies and the impact on patients. - [New features further strengthen EMA's Priority Medicines scheme (PRIME)](https://www.eucope.org/new-features-further-strengthen-emas-priority-medicines-scheme-prime/) - EMA introduces a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs. The main objective of this voluntary scheme is the enhanced interaction and early dialogue with developers of promising medicines, to continuously optimise development plans and speed up - [EUCOPE Member Spotlight: Q&A with Avanzanite Bioscience](https://www.eucope.org/eucope-member-spotlight-avanzanite-bioscience/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [?️Sounds of Science Podcast #14 on Trans-Atlantic Innovation](https://www.eucope.org/sounds-of-science-podcast-14-on-trans-atlantic-innovation/) - Our lates podcast discusses how the US and EU can work closer together to foster greater innovation that results in better access and treatments for patients. - [New date for pharmaceutical legislation proposal set for 26 April](https://www.eucope.org/new-date-for-pharmaceutical-legislation-proposal-set-for-26-april/) - After announcing the delay from the 29 March deadline, the European Commission is now expected to publish its proposal to revise the European Union’s pharmaceutical legislation on April 26, according to an agenda of Commission meetings published on 28 March 2023. Before the announcement, EU Health Commissioner Stella Kyriakides recently said the reform is needed - [OD Expert Group launches its policy proposals for the OMP Revision in a workshop in Parliament](https://www.eucope.org/od-expert-group-policy-proposals/) - On March 22, at a workshop in the European Parliament , the OD Expert Group presented its Policy Proposals for the revision of the OMP Regulation. - [EMA pilots scientific advice for certain high-risk medical devices](https://www.eucope.org/ema-pilots-scientific-advice-for-certain-high-risk-medical-devices/) - The European Medicines Agency (EMA) has launched a pilot to give scientific advice for certain high-risk medical devices - [Position Paper on Real World Evidence (RWE) across lifecycle of ATMPs](https://www.eucope.org/position-paper-on-real-world-evidence-rwe-across-lifecycle-of-atmps/) - The past 20 years have seen the gradual launch of advanced therapy medicinal products (ATMPs), in the EU, presenting patients with treatment options where, in some cases, no previous treatments were available. This pace in innovation is not expected to slow down, with five gene therapies alone approved in the EU in 2022. To ensure - [Council & Parliament adopted amendment to the MDR / IVDR](https://www.eucope.org/council-parliament-adopted-amendment-to-the-mdr-ivdr/) - The Council of the EU has officially adopted the amendment to the MDR and IVDR. This follows the positive vote from the European Parliament last month. - [EUCOPE adds nine new innovative members to its network](https://www.eucope.org/eucope-adds-nine-new-members-to-its-network/) - EUCOPE announced the joining of nine (9) new members at its quarterly Members Meeting on February 14th, 2023 following Board approval. - [Launch of the Nordic Rare Disease Summit 2023](https://www.eucope.org/launch-of-the-nordic-rare-disease-summit-2023/) - Join EUCOPE and its partners at the inaugural Nordic Rare Disease Summit 2023 taking place on 17 Aprile 2023 in Stockholm, Sweden. - [?️Sounds of Science #13 on Rare Disease Day 2023](https://www.eucope.org/sounds-of-science-podcast-rare-disease-day-2023/) - Sounds of Science Podcast - Episode 13 Rare Disease Day 2023: Improving equitable access and diagnosis for people living with a rare disease Between 27 and 36 million Europeans experience living with a rare disease. Every Rare Disease Day – taking place on 28 February – puts the spotlight back on the complexities surrounding people - [EUCOPE Member Spotlight: Q&A with BioCryst](https://www.eucope.org/eucope-member-spotlight-biocryst/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In February, we spoke with Sandra Nestler-Parr, Vice President, Value & Access, BioCryst Pharmaceuticals. Sandra Nestler-Parr is Vice President Value & Access at BioCryst Pharmaceuticals and responsible for pricing, - [EUCOPE Member Spotlight: Q&A with Enterome](https://www.eucope.org/eucope-member-spotlight-enterome/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [?️Sounds of Science #12 on the new EU HTA Procedure](https://www.eucope.org/sounds-of-science-12-on-the-new-eu-hta-procedure/) - On today’s episode, we review what’s happening with the EU HTA Procedure over the course of 2022 and what it means for developers and rare disease patients. - [European Parliament sets up new Public Health sub-committee](https://www.eucope.org/european-parliament-sets-up-new-public-health-sub-committee/) - On 14 February, the European Parliament voted to establish a dedicated Public health sub-committee, that will focus on public health, pharmaceutical and cosmetic products, health aspects of bioterrorism, the European Medicines Agency and the European Centre for Disease Prevention and Control. The sub-committee will comprise 30 members and will sit under ENVI, which will continue - [EUCOPE Member Spotlight: Q&A with Sobi - Swedish Orphan Biovitrum](https://www.eucope.org/eucope-member-spotlight-swedish-orphan-biovitrum-sobi/) - Every month, EUCOPE spotlights a member company and the great work they're doing to advance the life sciences industry and drive innovation to serve patients. - [EUCOPE signs joint letter on Data Act interplay with GDPR](https://www.eucope.org/eucope-signs-joint-letter-on-data-act-interplay-with-gdpr/) - On 25 January 2023, EUCOPE joined an industry coalition calling for better alignment of the Data Act with the GDPR Draft opinion by LIBE Committee as it risks curbing the benefits for innovation and is at odds with the Data Act’s objective to empower users. We are greatly concerned about the Data Act’s undermining of - [MDR/IVDR Implementation – the European Commission’s Proposal of 6 January 2023](https://www.eucope.org/mdr-ivdr-implementation-the-european-commissions-proposal-of-6-january-2023/) - As previously outlined in the EPSCO Council (Health) meeting on 9 December 2022 (Information Note), the European Commission adopted draft legislation on 6 January 2023 amending Regulations (EU) 2017/745 (Medical Devices Regulation – MDR) and (EU) 2017/746 (In Vitro Diagnostics Regulation – IVDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical - [Three new Associate Members join in 2023](https://www.eucope.org/three-new-members-join-in-2023/) - The European Confederation of Pharmaceuticals Entrepreneurs (EUCOPE) announced the joining of three (3) new Associate members on 1 January 2023. The new members joining EUCOPE network are: APCO Worldwide, RareLab and SKC. During the announcement, EUCOPE's Secretary General Alexander Natz said, "The new year means new collaborations and partnerships so we're delighted to add these - [?️Sounds of Science Episode 11 - 2022 Year in Review](https://www.eucope.org/sounds-of-science-2022-year-in-review/) - EUCOPE'S 2022 Year in Review: Our Policy team's perspectives on the past year in EU Health and a look ahead to 2023 - [?️Sounds of Science Episode 10 on Launch Conditionality](https://www.eucope.org/sounds-of-science-episode-10-on-launch-conditionality/) - This episode breaks down the potential impact of the launch condition on the small and mid-sized health technology companies in Euro - [‘Rare Disease Moonshot’ – Scaling-up public-private partnerships to accelerate research into world’s rarest diseases](https://www.eucope.org/rare-disease-moonshot/) - A new initiative to boost research and development into rare and paediatric diseases will launch today [Thursday 8 December] at the European Health Summit. - [EUCOPE Member Spotlight: Q&A with Ferrer](https://www.eucope.org/eucope-member-spotlight-qa-with-ferrer/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In October, we spoke with Óscar Perez, Chief Officer, Marketing, Pricing & Market Access and Business Development at Ferrer Internacional. Óscar Perez has a degree in Pharmacy from the University - [Three new members join EUCOPE before the end of 2022](https://www.eucope.org/six-new-members-join-before-end-2022/) - EUCOPE announced the joining of three (3) new members at its quarterly Members Meeting on October 19th following Board approval. - [Remap Consulting survey on the new EU HTA regulation](https://www.eucope.org/remap-consulting-survey-on-the-new-eu-hta-regulation/) - Remap Consulting has launched a short survey to gather feedback from biotech, pharmaceutical and medical device companies on the new EU HTA regulation. - [Expert Conference on Rare Diseases: Towards a New European Policy Framework: “Building the future together for rare diseases”](https://www.eucope.org/expert-conference-on-rare-diseases-towards-a-new-european-policy-framework-building-the-future-together-for-rare-diseases/) - Between 25-26 of October 2022, experts on rare diseases joined the Expert Conference on Rare Diseases in Prague organised by the Czech Presidency of the EU. - [EUCOPE Member Spotlight: Q&A with Grifols](https://www.eucope.org/eucope-member-spotlight-qa-with-grifols/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In October, we spoke with Cesar Rubio, Associate Director, Government and Public Affairs, Grifols. César Rubio is Associate Director, Corporate Affairs at Grifols, his background is in economics, and - [EUCOPE Member Spotlight: Q&A with PTC Therapeutics](https://www.eucope.org/eucope-member-spotlight-qa-with-ptc-therapeutics/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [EUCOPE/EFPIA Joint Statement: Concerns over the implementation of the EU HTA Regulation](https://www.eucope.org/eucope-efpia-joint-statement-eu-hta-regulation/) - EUCOPE and EFPIA's concerns on the current direction of the implementation of the EU HTA Regulation. - [Event Recap – TRANSFORM Alliance Charter Launch (13 October 2022)](https://www.eucope.org/event-recap-transform-alliance-charter-launch-13-october-2022/) - EUCOPE discusses solutions across the R&D lifecycle to build a European system fit for transformative therapies On the 13th of October 2022, the European Alliance for Transformative Therapies (TRANSFORM) came together with the MEP Interest Group to launch an MEP Charter in the European Parliament. The charter presents seven (7) main policy recommendations to promote - [Event Recap - Alexion's Rare Disease Policies (13 October 2022)](https://www.eucope.org/event-recap-alexions-rare-disease-policies-13-october-2022/) - On 13 October 2022, Alexion held a high-level conference, as part of the “Rare Conversations” event series, on rare disease policies in Brussels. - [?️Sounds of Science Episode 9 on ATMPs](https://www.eucope.org/🎙️sounds-of-science-episode-9-on-atmps/) - On our latest episode, we explore the topic of ATMPs and how they will be impacted by the General Pharmaceutical Legislation. - [Event Report: The revision of the EU legal framework for orphan drugs and its impact on Germany](https://www.eucope.org/event-report-the-revision-of-the-eu-legal-framework-for-orphan-drugs-and-its-impact-on-germany/) - On September 5, 2022, EUCOPE and BPI organised an online event on the revision of the EU regulatory framework for orphan drugs and its impact on Germany. - [EUCOPE Member Spotlight: Q&A with AOP Health](https://www.eucope.org/eucope-member-spotlight-qa-with-aop-health/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In September, we spoke with Johanna Grames, Senior Manager, International Government Affairs & Health Economics, AOP Health. Johanna Grames is Senior Manager for International Governmental Affairs and Health Economics - [EUCOPE Member Spotlight: Q&A with Guardant Health](https://www.eucope.org/member-spotlight-guardant-health/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [?️Sounds of Science Episode 8 on the European Health Data Space (EHDS)](https://www.eucope.org/sounds-of-science-episode-8-on-the-european-health-data-space-ehds/) - A podcast discuss the inherent challenges and what it will take to deliver on the ambitious promise of the European Health Data Space (EHDS) - [EUCOPE co-signs letter calling for a European Action Plan on Rare Diseases](https://www.eucope.org/eucope-co-signs-letter-calling-for-a-european-action-plan-on-rare-diseases/) - EUCOPE co-signed EURORDIS’ letter calling on the European Commission to take forward the conclusions of the conference for a European Action Plan on Rare Diseases. - [On the update of the Blood, Tissues and Cell (BTC) Legislation](https://www.eucope.org/on-the-update-of-the-blood-tissues-and-cell-btc-legislation/) - Under the Commission’s proposal, the two Directives will be rolled into one Regulation, the SoHO (Substances of Human Origin) Regulation. - [EUCOPE joins the Joint Industrial Cooperation Forum of HERA](https://www.eucope.org/eucope-joins-the-joint-industrial-cooperation-forum-of-hera/) - EUCOPE has been selected to join the Joint Industrial Cooperation Forum (JICF), a sub-group of the HERA Forum. - [?️Sounds of Science - Episode 7 on Unmet Medical Needs (UMN)](https://www.eucope.org/🎙️sounds-of-science-episode-7-on-unmet-medical-needs-umn/) - The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days. Listen to EUCOPE's latest podcast episode on UMN. - [Partnerships in Focus: Q&A with FIPRA's Sheela Upadhyaya](https://www.eucope.org/partnerships-in-focus-qa-with-fipras-sheela-upadhyaya/) - Our Partnerships in Focus series highlights associates that we partner with to co-create solutions for various challenges across the healthcare ecosystem. - [SURVEY: Medical Device Regulation (MDR) for European Innovators](https://www.eucope.org/survey-medical-device-regulation-mdr-for-european-innovators/) - The objective of this survey is to capture the consequences of the Medical Devices Regulation (MDR) on innovative European companies - [Event Recap: 'The Future of Rare Diseases in Europe & Czech Republic' Webinar](https://www.eucope.org/event-recap-the-future-of-rare-diseases-in-europe-czech-republic-webinar/) - EUCOPE hosted a virtual roundtable on the future of rare diseases in Europe and the Czech Republic on Monday, 20 June 2022. - [Six new members join the EUCOPE network](https://www.eucope.org/six-new-members-join-the-eucope-network/) - The European Confederation of Pharmaceuticals Entrepreneurs (EUCOPE) announced the joining of six (6) new members at its Members Meeting on June 22 2022. - [EUCOPE Member Spotlight: Q&A with Alnylam](https://www.eucope.org/eucope-member-spotlight-qa-with-alnylam/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better - [EUCOPE and MassBio strengthen trans-Atlantic ties through partnership agreement](https://www.eucope.org/eucope-and-massbio-strengthen-trans-atlantic-ties-through-partnership-agreement/) - EUCOPE and MassBio have signed an agreement to foster innovation and collaborations in business and research among their members. - [EUCOPE Member Spotlight: Q&A with Amgen](https://www.eucope.org/eucope-member-spotlight-qa-with-amgen/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better - [?️Sounds of Science - Episode 6 on Cross-Border Healthcare](https://www.eucope.org/🎙️sounds-of-science-episode-6-on-cross-border-healthcare/) - On our latest podcast, we discuss the challenges and opportunities available to improve access for rare disease patients through cross-border healthcare. - [Partnerships in Focus: Q&A with Alexion-AstraZeneca's Maciej Gajewski](https://www.eucope.org/partnerships-in-focus-qa-with-alexion-astrazenecas-maciej-gajewski/) - Our Partnerships in Focus series highlights associates that we partner with to co-create solutions for various challenges across the healthcare ecosystem. - [EUCOPE Member Spotlight: Q&A with CSL Behring](https://www.eucope.org/eucope-member-spotlight-qa-with-csl-behring/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [Partnerships in Focus: Q&A with Takeda's Toon Digneffe](https://www.eucope.org/partnerships-in-focus-qa-with-takedas-toon-digneffe/) - For the first edition of our Partnerships in Focus series, we speak with Toon Digneffe, Head of Public Affairs and Partnerships Public Policy of Takeda. - [On the upcoming Regulation Proposal on the European Health Data Space (EHDS)](https://www.eucope.org/on-the-upcoming-regulation-proposal-on-the-european-health-data-space-ehds/) - In view of the upcoming Regulation proposal of the European Health Data Space (EHDS), EUCOPE reiterates its position to assist the EU in becoming a leader in digital innovation. - [?️Sounds of Science Podcast - Episode 5 on Increasing Access to Genomic Testing in Europe](https://www.eucope.org/sounds-of-science-podcast-episode-5-on-increasing-access-to-genomic-testing-in-europe/) - On our latest podcast, we look at some of the measures that leading EU Member States have taken to pave the way toward wider access to genomic testing - [EUCOPE Member Spotlight: Q&A with MorphoSys](https://www.eucope.org/eucope-member-spotlight-qa-with-morphosys/) - Every month, we spotlight a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [?️Sounds of Science – EUCOPE Podcasts](https://www.eucope.org/sounds-of-science-eucope-podcasts/) - Today marks the release of the first episode of Sounds of Science, a series of podcasts organized by EUCOPE, discussing pressing EU files and presenting the point of view of EUCOPE and its members in an informative and interactive way. In this first podcast, Ana Palma, Senior Director Global Head of Market Access & Access - [?️Sounds of Science Podcast - EPISODE 4 on EU Rare Disease Legislation](https://www.eucope.org/sounds-of-science-podcast-rare-disease/) - Episode 4 gives you more detail on the background of the OMP revision, as well as the possible outcomes and implications for the rare disease community. - [EUCOPE Member Spotlight: Q&A with Norgine](https://www.eucope.org/eucope-member-spotlight-qa-with-norgine/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to drive healthcare innovation in Europe to serve patients better. - [EUCOPE Member Spotlight: Q&A with Circius Pharma](https://www.eucope.org/eucope-member-spotlight-circius-pharma/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to drive healthcare innovation in Europe to serve patients better. - [PharmaBoardroom Opinion: New EU HTA Procedure - Will it Reduce the Complexity and Burdens for Manufacturers?](https://www.eucope.org/pharmaboardroom-opinion-new-eu-hta-procedure-will-it-reduce-the-complexity-and-burdens-for-manufacturers/) - In this op-ed for PharmaBoardoom, EUCOPE’s Secretary-General Dr. Alexander Natz sees both opportunities and pitfalls with the EU HTA procedure. - [EUCOPE Member Spotlight: Q&A with Jazz Pharmaceuticals](https://www.eucope.org/eucope-member-spotlight-jazz-pharmaceuticals/) - EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. - [EUCOPE's reaction to the Regulation for a European Health Data Space (EHDS)](https://www.eucope.org/eucopes-reaction-to-the-regulation-for-a-european-health-data-space-ehds/) - EUCOPE welcomes the launch of the European Health Data Space (EHDS) and its objective to enable better exchange and access to different types of health data. - [Modernising the Centralised Procedure: Our Proposal for Reform](https://www.eucope.org/modernising-the-centralised-procedure-our-proposal-for-reform/) - EUCOPE's latest position paper outlines our vision for the evolution of the EU Regulatory framework and a modernisation of the Centralised Procedure. - [The Implications Of The New EU HTA Regulation For Companies](https://www.eucope.org/the-implications-of-the-new-eu-hta-regulation-for-companies/) - Alexander Natz highlights the potential impact for health technologies subject to JCAs, from the choice of comparator to the importance of scientific advice. - [EUCOPE adds five new members to its association](https://www.eucope.org/eucope-adds-five-new-members-to-its-association/) - As the EU trade body for small to mid-sized health technologies companies, EUCOPE is happy to welcome five new members to its organisation. - [EUCOPE Member Spotlight: Q&A with Organon](https://www.eucope.org/eucope-member-spotlight-organon/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to drive healthcare innovation in Europe to serve patients better. - [EUCOPE Member Spotlight: Q&A with Ferring Pharmaceuticals](https://www.eucope.org/eucope-member-spotlight-ferring-pharmaceuticals/) - Every month, EUCOPE spotlights a member company and the great work they’re doing to drive healthcare innovation in Europe to serve patients better. - [OD Expert Group kicks off Phase 2](https://www.eucope.org/od-expert-group-kicks-off-phase-2/) - The multi-stakeholder European Expert Group on Orphan Drug Incentives (OD Expert Group) has announced the kick-off of Phase 2 of its work on 29 March. - [Reinforcing Europe as a centre for pharmaceutical innovation](https://www.eucope.org/reinforcing-europe-as-a-centre-for-pharmaceutical-innovation/) - Alexander Natz writes about the need for a flexible legislative framework to promote European competitiveness on a global stage. - [EUCOPE speaks on how Europe can be a global leader in the innovation in rare diseases](https://www.eucope.org/eu-innovation-in-rare-diseases/) - EUCOPE's Alexander Natz discusses the need for a holistic, integrated, and well-functioning EU environment to foster innovation and re-invest in R&D - [New EMA/HMA pilot on medicines repurposing](https://www.eucope.org/new-ema-hma-pilot-on-medicines-repurposing/) - The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) launched a pilot to support the repurposing of medicines. The pilot is being carried out as a follow-up to the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) discussions on a proposal for a medicines repurposing framework. - [Event report: European Health Forum Gastein: A better tomorrow for rare disease care and research](https://www.eucope.org/event-report-european-health-forum-gastein-a-better-tomorrow-for-rare-disease-care-and-research/) - EUCOPE, in partnership with Sanofi, participated in the European Health Forum Gastein 2021 (EHFG) on 29 September in a session on rare diseases to discuss what is needed to stimulate basic research, clinical development, and access to care across the EU in light of the EU Orphan Medicinal Product (OMP) Regulation Review. The OMP Regulation - [EUCOPE Event: Health 4.0 post-COVID](https://www.eucope.org/eucope-event-health-4-0-post-covid/) - Join experts on 27 January, to discuss how a fit-for-purpose environment can help develop AI and the digitalisation of healthcare. Hearing the priorities of the Portuguese presidency and the European Commission's plans on digital health, panellists will share ideas on: How can the EU facilitate the implementation of AI-based technologies? How can policy-makers address the - [EJP RD - Networking event for interested parties](https://www.eucope.org/ejp-rd-networking-event-for-interested-parties/) - On the 3rd of March, in Paris, France, the Rare Diseases Research (RDR) initiative will organise a networking event for SMEs, academia and interested stakeholders to take part in research project targeting specific rare diseases challenges. Within the framework of the European Joint Programme on Rare Diseases, the Rare Diseases Research (RDR) initiative aims to - [EURORDIS Black Pearl Awards 2020: Nominations open!](https://www.eucope.org/eurordis-black-pearl-awards-2020-nominations-open/) - The nominations for the EURORDIS Black Pearl Awards 2020 are now open until 13 September 2019! The Black Pearl Awards is an annual event organised by EURORDIS, the alliance of more than 800 rare disease patient organisations, to recognise the outstanding achievements and exceptional work of people making a difference for the rare disease community. - [EUCOPE Webinar: Future of Rare Disease Innovation in Europe](https://www.eucope.org/free-webinar-future-of-rare-disease-innovation-in-europe/) - EUCOPE invites you to an online discussion on the future of rare diseases innovation to the benefit of patients in Europe. Entitled 'How can Europe remain at the forefront of innovation to the benefit of patients with rare diseases?', the event will take place online on 8 July, 11.00 - 12.00 CET. The COVID-19 pandemic - [EUCOPE Response Statement – Pharmaceutical Strategy Roadmap](https://www.eucope.org/eucope-response-statement-pharmaceutical-strategy-roadmap/) - EUCOPE examined with great interest the European Commission’s Pharmaceutical Strategy Roadmap. We welcome the European Commission’s acknowledgement of the crucial role played by the pharmaceutical sector in the economy of the EU, as well as the creation of a future-proof, knowledge-intensive European Union. We share the objective of the European Commission to build a holistic, - [The OMP Regulation in context: EU environment for the development of OMPs](https://www.eucope.org/omp-regulation-the-way-forward/) - EUCOPE’s approach to the EU environment for the development of OMPs On 11 August 2020, the European Commission published its evaluation on the legislation for medicines for rare diseases and for children. In November this was followed by an Inception Impact Assessment outlining policy options based on the outcomes of the evaluation. EUCOPE seize the - [Response to the OMP & Paediatric Consultation- A Call for a Constructive Conversation](https://www.eucope.org/response-to-the-omp-paediatric-consultation-a-call-for-a-constructive-conversation/) - The European Commission is consulting stakeholders as part of its revision process of two major pieces of legislation, on medicines for rare diseases and paediatric patients. Central to the development of innovative treatments for these specific categories of patients, this revision process represents an important milestone for the European industry and patients’ communities. Published on - [European Health Data Space: Enabling Future Innovation](https://www.eucope.org/european-health-data-space-enabling-future-innovation/) - As proven by the fight against COVID-19, data and digital health have the potential to drive change and improve efficiency and accessibility in healthcare. To make the most of this enormous potential, the European Commission opened a public consultation on the European Health Data Space, one of its most ambitious initiatives, aiming to embrace the - [Cross-border healthcare for ATMPs patients: Our Solutions](https://www.eucope.org/cross-border-healthcare-for-atmps-patients-our-solutions/) - The complexities related to delivering some Advanced Therapy Medicinal Products (ATMPs) most likely will require highly specialized clinical expertise and infrastructures, which currently do not exist in all EU counties. Therefore, relocating or crossing borders often represent the only solution for many patients. A well-developed and highly functioning cross-border healthcare framework at the EU level - [OrphVal](https://www.eucope.org/orphval/) - Working group of European rare disease experts developed nine principles to foster greater consistency in Value Assessment and Funding Process in rare diseases. The group explored the pricing and reimbursement systems for OMPs in selected European countries to analyse where they align with or diverge from the nine principles suggested in the original OrphVal report. OrphVal - [RWE4Decisions](https://www.eucope.org/rwe4decisions/) - Multi-stakeholder initiative commissioned by the Belgian National Institute of Health and Disability Insurance (INAMI-RIZIV) aimed at fostering stakeholders’ agreement of what real-world data (RWD) can be collected for highly innovative technologies, to generate real-world evidence (RWE) that informs decisions by healthcare systems, clinicians and patients. RWE4Decisions - [European Expert Group on OD Incentives](https://www.eucope.org/european-expert-group-on-od-incentives/) - Multidisciplinary expert group including researchers, academia, patient representatives, investors and industry Input to strengthen the OMP Incentives Environment in Europe focusing on addressing unmet needs and supporting delivery of continued innovation where treatments exist; finding ways to optimise and accelerate OD regulatory pathways and identifying actions to support OD development and industry & academia collaboration. - [OMP and Paediatric Regulations General Consultation](https://www.eucope.org/omp-and-paediatric-regulations-general-consultation/) - On 7 May, the European Commission opened its public consultation on the revision of EU rules on medicines for children and rare diseases. The consultation, aimed at stakeholders and members of the general public, including patients and doctors, will explore several options to address the shortcomings identified in the evaluation of the Regulations on medicines for - [OD Expert Group unveils Policy Proposals to address Unmet Needs in Rare Diseases](https://www.eucope.org/od-expert-group-unveils-policy-proposals-to-address-unmet-needs-in-rare-diseases/) - The multidisciplinary European Expert Group on Orphan Drug Incentives (OD Expert Group) has developed fourteen innovative proposals along the entire lifecycle of orphan drug development to address the unmet needs in rare diseases. With over ninety percent of patients without a centrally approved treatment option, the need for innovation and research into orphan drugs is - [Evaluation of Pharmaceutical Legislation: EUCOPE's Response](https://www.eucope.org/evaluation-of-pharmaceutical-legislation-eucopes-response/) - The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness. In its response to the EU roadmap/IIA on the “Evaluation and revision of the general pharmaceutical legislation”, EUCOPE puts forward its priorities for - [Joint pharmaceutical industry statement on the Commission’s proposal for a Regulation on health technology assessment (HTA)](https://www.eucope.org/joint-pharmaceutical-industry-statement-on-the-commissions-proposal-for-a-regulation-on-health-technology-assessment-hta/) - The pharmaceutical industry represented by AESGP[1], EFPIA[2], EUCOPE[3], EuropaBio[4], Medicines for Europe and PPTA[5] – henceforth referred to as ‘the pharmaceutical industry’ – generally welcomes the European Commission (EC)’s Proposal for a Regulation on HTA[6]. We understand the scope of the joint clinical assessments foreseen in the proposal is limited to medicinal products subject to - [EUCOPE Statement on Council HTA compromise - March 2021](https://www.eucope.org/eucope-statement-on-council-hta-compromise-march-2021/) - EUCOPE welcomes the important collaborative effort made by the Council of the EU to reach a compromise on the EU on a Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU. However, we note that the direction of the current compromise is substantially changing central parts of the proposed Regulation. We - [Event Report: What does it take for Europe to stay at the forefront of rare diseases innovation?](https://www.eucope.org/event-what-does-it-take-for-europe-to-stay-at-the-forefront-of-rare-diseases-innovation/) - In the past two decades, a combination of scientific breakthrough coupled with strong incentives systems brought about great progress for rare disease patients. The number of medicines approved in Europe to treat rare diseases since 2000 increased from 8 to 169. However, with 95% of rare diseases conditions still without treatment, the need for science - [Press Release: EU HTA Proposal - Council on the verge of a compromise?](https://www.eucope.org/press-release-eu-hta-proposal-council-on-the-verge-of-a-compromise/) - EUCOPE welcomes the important collaborative effort made today 16 March by the Council of the EU to reach a compromise on the EU on a Proposal for a Regulation on health technology assessment (HTA) and amending Directive 2011/24/EU. The Portuguese Presidency underscored the difficulty of the ongoing negotiation and the need for additional political discussion - [Brexit: Maintaining the exchange of health data](https://www.eucope.org/brexit-maintaining-the-exchange-of-health-data/) - A large consortium of European health-related stakeholders, including industry players, academia, healthcare professionals and patients, share their satisfaction on the draft adequacy decision on the UK data protection regime issued by the European Commission on 19th February 2021. Protecting the benefits of the free flow of personal data must be a top priority. The absence - [TRANSFORM: Multi-stakeholder approach to gene and cell therapies](https://www.eucope.org/transform-multi-stakeholder-approach-to-gene-and-cell-therapies/) - Following a successful launch event, the TRANSFORM MEP Interest Group, a multi-stakeholder alliance of Members of European Parliament, patient groups, academia and industry, published two important documents to lay the foundations of an open discussion on key priorities for gene and cell therapies, namely a Call to Action and a Consensus Statement. The two documents - [Blog Post: HERA - Just another new EU agency?](https://www.eucope.org/blog-post-hera-just-another-new-eu-agency/) - Last January, the European Commission launched the consultation on the European Health Emergency Preparedness and Response Authority, HERA for short. How can we make sure this new agency finds its way? Clarity on its roles and responsibilities will be needed. See our take in this new blog post: https://blog.eucope.org/2021/hera-closer-coordination-in-the-eu-against-covid-19/ - [Revision of the Public Health Insurance Act in Czech Republic](https://www.eucope.org/revision-of-the-public-health-insurance-act-in-czech-republic/) - The Czech Ministry of Health recently announced that the Public Health Insurance Act 48/1997, which regulates the scope and conditions under which health services are covered as well as their pricing and reimbursement, would be amended. The foreseen amendments, expected to enter into force in Q1 2020, include: New rules regarding the assessment of innovative - [Rare Disease Day: Celebrating an empowered community](https://www.eucope.org/rare-disease-day-celebrating-an-empowered-community/) - On Rare Diseases Day, EUCOPE is delighted to host an interview with Laurence Woollard, patient expert and rare disease advocate, to discuss with him the importance of an engaged community and the opportunities and challenges new treatments can bring. See Laurence's Q&A on our blog. - [COVID-19: Need for undisrupted access to treatment in hospitals](https://www.eucope.org/covid-19-the-challenge-of-treatments-for-life-threatening-conditions/) - The COVID-19 pandemic creates an extraordinary situation for all stakeholders. EUCOPE members are particularly concerned with the impact the COVID-19 crisis created on clinical development. Delay of patients’ access to innovative treatment The delay caused by the pandemic in drug development is in particular concerning in the area of investigations on unmet medical need and - [Consultation on EU Pharmaceutical Strategy](https://www.eucope.org/consultation-on-eu-pharmaceutical-strategy/) - The European Commission just opened the public consultation on its proposed pharmaceutical strategy for the EU. In the Commission's words, the strategy intends to 'address the current issues of access, availability and affordability of medicines, while still promoting sustainable innovation and support EU industry to remain an innovator and world leader. It also aims to - [Sickle Cell Disease: An European Overview](https://www.eucope.org/sickle-cell-disease-an-european-overview/) - Sickle cell disease is one of the most prevalent genetic diseases in Europe. A recent report, commissioned by our member company Global Blood Therapeutics, use the latest data from 5 EU countries to draw recommendations to improve the life expectancy of people living with this condition. The report is available here https://ir.gbt.com/static-files/29a0775c-ed27-4778-8c10-90dbb9ae1f09 - [EMA & HMA Joint Strategy 2021-2025](https://www.eucope.org/ema-hma-joint-strategy-2021-2025/) - Published on 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) Joint Strategy looks into six strategic focus areas: (1) Availability and accessibility of medicines, (2) Digital tools and digital transformation, (3) Innovation, (4) Antimicrobial resistance, (5) Supply chain challenges, and (6) Sustainability of the Network. The document lays down four - [1st International Conference on Rare Diseases](https://www.eucope.org/1st-international-conference-on-rare-diseases/) - EUCOPE has the pleasure to participate to the 1st International Conference on Rare Diseases organised under the patronage of H.E. the President of the Hellenic Republic. The event, entitled “Building a Pathway from Diagnosis to Access” will take place virtually on the first and second of March . Alexander Natz, EUCOPE’s Secretary General, is invited - [EC Conference: “Medicines for Rare Diseases & Children: Learning from the Past, Looking to the Future”](https://www.eucope.org/ec-conference-medicines-for-rare-diseases-children-learning-from-the-past-looking-to-the-future/) - On 17 June 2019, the EU Commission (EC) will gather a large spectrum of stakeholders from the Member States, patients, academia, healthcare professionals and industry to collect their views on the successes and limitations of the regulatory framework for Paediatric medicines and Orphan Medicinal Products (OMPs). This event is set against the background of the - [Harnessing Europe’s untapped potential: small and medium pharma](https://www.eucope.org/harnessing-europes-untapped-potential-small-and-medium-pharma/) - EUCOPE asks the European Commission to put research at the heart of its Pharmaceutical Strategy The European Commission’s Pharmaceutical Strategy for Europe must: Provide ambitious measures to foster research in rare diseases and other disease areas for which we currently have no cure. Harness the potential of small and medium pharmaceutical and medical technology companies. - [Study: Economic & Financial Challenges of Developing Orphan Drugs](https://www.eucope.org/study-economic-financial-challenges-of-developing-omps/) - In a study commissioned by EUCOPE, the Office of Health Economics (OHE) assessed the extent to which the Orphan Medicinal Products (OMPs) Regulation (2000/018) has successfully incentivised companies to invest in research and development of OMPs. The study also puts forward an analysis of the financial challenges of developing OMPs, and what the implications of - [Hospital Exemption for ATMPs: Our Recommendations](https://www.eucope.org/hospital-exemption-for-atmps-our-recommendations/) - Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury, bringing with them the promise of treatment of severe, disabling or life-limiting conditions but also the promise of one-time disease-modifying and potentially curative treatments that - [A 20th Anniversary Analysis of the EU OMP Regulation](https://www.eucope.org/a-20th-anniversary-analysis-of-the-eu-omp-regulation/) - The 10th European Conference on Rare Diseases (ECRD), the largest patient-led event on rare diseases and orphan products, presented an excellent opportunity for exchange among the patient community and experts from various backgrounds. The conference allowed EUCOPE to share the key findings of the study EUCOPE commissioned to the Office of Health Economics aimed at - [EUCOPE response to the EC Pharmaceutical Strategy Roadmap](https://www.eucope.org/eucope-response-to-the-ec-pharmaceutical-strategy-roadmap/) - On the verge of the publication of the EU industrial strategy in March, EUCOPE shared the expectations and ambitions of its membership for a coherent strategy that harness Europe’s untapped potential: small and medium biopharma. The mission letter from President von der Leyen to Commissioner Kyriakides calls for measures supporting the European pharmaceutical industry in remaining - [Press Release: Study on Orphan Regulation](https://www.eucope.org/press-release-evaluation-of-orphan-and-paediatric-regulations/) - EUCOPE, the European association for small to medium-sized companies in the field of pharmaceuticals, biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the study on the EU Regulation 141/2000 on Orphan Medicinal Products (OMPs) (here below). The study aims to inform the upcoming European Commission evaluation - [Evaluation of EU legislation on Orphan Medicinal Products (OMPs) and Paediatric Medicines](https://www.eucope.org/evaluation-of-eu-legislation-on-orphan-medicinal-products-omps-and-paediatric-medicines/) - Brussels 11 August 2020 - EUCOPE, the European association for small to medium-sized companies in the field of pharmaceuticals, biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the evaluation of EU legislation on Orphan Medicinal Products (OMPs) and Paediatric Medicines. Focusing on the impact of the - [EU Pharmaceutical Strategy: Value chain approach with innovation leadership at its core](https://www.eucope.org/eu-pharmaceutical-strategy-value-chain-approach-with-innovation-leadership-at-its-core/) - Earlier this Summer the European Commission published its Roadmap for the Pharmaceutical Strategy for Europe which paved the way for a consultation process to which EUCOPE has contributed and will continue engage in the next months. Our position paper accompanying the general consultation is available here. EUCOPE’s members, small to medium-sized companies active in pharmaceuticals, - [EC Pharmaceutical Strategy - Time for a Modern Approach to Value](https://www.eucope.org/ec-pharmaceutical-strategy-time-for-a-modern-approach-to-value/) - EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe. EUCOPE calls for a comprehensive Pharmaceutical Strategy that adopts a value chain approach, encompassing European manufacturing and - [EMA Workshop on support for orphan medicines development](https://www.eucope.org/ema-workshop-on-support-for-orphan-medicines-development/) - On 30/11, the European Medicines Agency (EMA) will organise a virtual event to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. The meeting will highlight and explain existing tools in the context of early product development strategy. These include:​ orphan designation; protocol assistance; the PRIority MEdicines (PRIME) scheme. - [Event Report: Case studies on rare disease therapies development](https://www.eucope.org/event-report-case-studies-on-rare-disease-therapies-development/) - Aware of the complex European policy landscape that will keep policymakers busy in the months to come, EUCOPE wanted to discuss the European innovation leadership in the pharmaceutical sector and discover how the European Union and Member States can support pharmaceutical innovation in Europe. On 20 November, a few days before the publication of the - [EUCOPE’s response to the Orphan Medicinal Products and Paediatrics Inception Impact Assessment](https://www.eucope.org/eucopes-response-to-the-orphan-medicinal-products-and-paediatrics-inception-impact-assessment/) - EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies submitted its response to the Paediatric and Orphan Medicinal Products (OMPs) inception impact assessment. EUCOPE represents 130 companies, many focused on rare diseases, largely small to medium-sized, playing a key role in the European pharmaceutical environment. Some of them have unique - [Artificial Intelligence in Health: A European Opportunity](https://www.eucope.org/artificial-intelligence-in-health-a-european-opportunity/) - As demonstrated by the fight against COVID-19, Artificial Intelligence (AI) has the potential to drive change and improve efficiency and accessibility in healthcare. From compounds design in medicines development to faster patient screening and diagnosis to hospital management (to name but a few applications), AI-based solutions can help upgrade our healthcare systems towards more sustainability, - [Communications & Events Internship Opportunity at EUCOPE](https://www.eucope.org/internship-opportunity-at-eucope/) - EUCOPE is looking for a new Communications & Events intern to join its team in Brussels! Starting ideally as of 1 March, the successful candidate will cover all kind of online communications activities as well as supporting the organisation of events. Please see the detailed description of the offer here below. Should you be interested, - [Paper: New Payment & Funding Approaches for ATMPs](https://www.eucope.org/paper-new-payment-funding-approaches-for-atmps/) - The recent years have seen a number of high-end innovative therapies becoming accessible to patients in Europe. These products offer groundbreaking new opportunities to patients living with rare diseases or cancer, with the capacity of often one-time disease-modifying and potentially curative treatments. This new generation of therapies calls for a new paradigm of care, where - [European Alliance for Transformative Therapies - Launch](https://www.eucope.org/european-alliance-for-transformative-therapies-launch/) - On 8 December, the European Alliance for Transformative Therapies, a broad alliance of Members of European Parliament, patient groups, European Reference Networks, academia and industry, will be officially launched in a virtual meeting from 16.00 to 17.30. The Alliance, supported by MEPs Claudia Gamon (RE, Austria), Ondrej Knotek (RE, Czechia) and Tomislav Sokol (EPP, Croatia) - [Brexit: Guidance on Supplying Medicines to Northern Ireland](https://www.eucope.org/brexit-guidance-on-supplying-medicines-to-northern-ireland/) - According to the MHRA Guidance, up until 31 December 2021, medicines can be supplied from Great Britain (GB) to Northern Ireland (NI) with a “pragmatic approach” to applying EU rules on importation and unique identifier requirements. Outside of these two areas, medicines supplied to NI have to follow EU rules (as set out in the NI - [Join us: RARE Conversations Breakfast Briefing](https://www.eucope.org/join-us-rare-conversations-breakfast-briefing/) - RARE Conversations Breakfast Briefing Impact of COVID-19 on Pharmaceutical Research and Development in Rare Diseases 3 December 2020 | 10.00 - 11.15 CET via Zoom Europe has long been at the forefront in healthcare and is home to many leading healthcare professionals, academia and the innovative pharmaceutical industry that together have fought relentlessly to - [Blog Article: Is it Time for a New Health Paradigm in the EU](https://www.eucope.org/blog-article-is-it-time-for-a-new-health-paradigm-in-the-eu/) - In the follow-up of Commission President von der Leyen's intention to shape a resilient European Health Union, the Commission services announced on 11 November the publication of a Communication on Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats accompanied by three proposals for Regulations. Read the analysis of this important - [EUCOPE-BIO Webinar: Maintain the innovation ecosystem at all costs](https://www.eucope.org/eucope-bio-webinar-maintain-the-innovation-ecosystem-at-all-costs/) - The EU and US Biotech Sector’s Response to COVID-19 On 24 September, EUCOPE, together with BIO, hosted a webinar focusing on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and US. The objective of the webinar was to understand the - [EU Health Summit 2020: Time for Action](https://www.eucope.org/eu-health-summit-2020-time-for-action/) - EUCOPE, together with 33 other stakeholders active in health is delighted to invite you to the second EU Health Summit on 26 October. COVID-19 has exacerbated many of the existing, underlying problems of healthcare systems. The current crisis has clearly demonstrated how healthy populations and economic growth are interdependent and mutually reinforcing. This public health - [Event: Will a No-Deal Brexit endanger Patient Safety?](https://www.eucope.org/event-will-a-no-deal-brexit-endanger-patient-safety/) - EUCOPE, together with 16 associations representing patients, healthcare professionals and the pharmaceutical and devices industry have joined efforts in supporting the event "Brexit: the European Parliament’s role in prioritising patients, public health and health security across Europe", to be held on September the 12th in the European Parliament in Brussels. The event will focus on - [ECRD - The European Conference on Rare Diseases & Orphan Products](https://www.eucope.org/ecrd-the-european-conference-on-rare-diseases-orphan-products/) - On the 14 and 15 May, the European Conference on Rare Diseases & Orphan Products (ECRD) will gather patients, academia, research and the industry in a collaborative online dialogue, learning and conversation take place, forming the groundwork to shape future rare disease policies. It is a biennial event, providing the state-of-the-art of the rare disease - [SME Connect Webinar: Role of SMEs in fighting COVID-19](https://www.eucope.org/sme-connect-webinar-role-of-smes-in-fighting-covid-19/) - EUCOPE has been invited to speak at the next webinar organised by SME Connect, to discuss the needs of and important role played by small and medium-sized companies in the fight against COVID-19. EUCOPE will be represented by Alexander Natz, EUCOPE Secretary General. Other panellists include Christian Ehler, MEP and representatives from other trade associations - [Event: Securing Drug Supply and Patient Access in Europe](https://www.eucope.org/event-securing-drug-supply-and-patient-access-in-europe/) - EUCOPE, together with experts from Ministries, HTA agencies and pharmaceutical companies, will take part in the next FORUM Event in Berlin on 9 July 2020. The seminar will give the opportunity to discuss, inter alia, the priorities of the German Presidency of the EU on the supply of medicines and devices in Europe and optimise - [2nd EUCOPE/DIA Workshop on ATMPs in the EU](https://www.eucope.org/2nd-eucope-dia-workshop-on-atmps-in-the-eu/) - On 27 and 28 May, EUCOPE and Drug Information Association (DIA) jointly organise an online workshop on ATMPs and Innovative Gene and Cell Therapies. The event is a unique opportunity to hear directly from the Industry and Regulatory representatives about the challenges, opportunities and political implications of advanced therapies. This workshop will include a wide - [EUCOPE - BIO Webinar: The EU and US Biotech Sector’s Response to COVID-19](https://www.eucope.org/eucope-bio-webinar-impact-of-covid-in-the-us-vs-the-eu/) - On 24 September, EUCOPE, together with BIO, will host a webinar focused on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and US. The agenda will tackle: Measures taken by regulatory and policy institutions in the EU and US, and - [EUCOPE Members and General Meeting on 14 October 2020](https://www.eucope.org/eucope-members-and-general-meeting-on-14-october-2020/) - Given the most recent travel restrictions to and from Belgium, we would like to inform you that the EUCOPE Board has decided to have the upcoming General and Members Meetings on 14 October in a virtual format only and not in the originally planned hybrid form. We hope that this limitation to remote access does - [Need for a Mutual Recognition Agreement between the EU and UK](https://www.eucope.org/need-for-a-mutual-recognition-agreement-between-the-eu-and-uk/) - EUCOPE, together with other European pharmaceutical trade associations, wrote a letter to the presidents of the Commission, Council and Parliament, as well as Trade Commissioner Phil Hogan and the EU’s chief negotiator Michel Barnier, voicing our shared concern about the lack of progress within the negotiations between the UK and the EU with only 6 - [UK Initiative on Rapid Patient Access to COVID-19 Treatments](https://www.eucope.org/uk-initiative-on-rapid-patient-access-to-covid-19-treatments/) - As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives for the acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines In - [COVID-19: EMA accelerates its Regulatory Process](https://www.eucope.org/covid-19-ema-accelerates-its-regulatory-process/) - The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every step of a medicine’s regulatory pathway. Faster support in the - [ECDC - Q&A on COVID-19](https://www.eucope.org/ecdc-qa-on-covid-19/) - The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical implications concerning the need for travel, the link between the diseases and animals, etc. In - [The Medical Devices Regulation officially postponed by one year](https://www.eucope.org/the-medical-devices-regulation-officially-postponed-by-one-year/) - On 3 April, the European Commission adopted a proposal to postpone by one year the application of the Medical Devices Regulation (MDR). Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April. The amending Regulation 2020/561 (attached) has been published in the Official Journal on 24 - [EMA Q&A Document on Regulatory Flexibility: Updates on GMP/GDP](https://www.eucope.org/ema-qa-document-on-regulatory-flexibility-updates-on-gmp-gdp/) - The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The measures are detailed in the latest version of the Q&A - [COVID-19: EUCOPE Calls for more Regulatory Flexibility](https://www.eucope.org/covid-19-eucope-calls-for-more-regulatory-flexibility/) - Following the recent EMA guidance on clinical trials management during COVID-19, EUCOPE calls the EMA and all national authorities to allow for flexibility in these exceptional times. In addition, EUCOPE recommends the following: Standardised Approaches: all stakeholders involved in discussing the COVID-19 response make best efforts to align across Member States as much as possible - [Q&A Document on Regulatory Expectations during COVID-19](https://www.eucope.org/qa-document-on-regulatory-expectations-during-covid-19/) - The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic. The Q&A document includes information on legal and regulatory guidance on MAs/MAs procedures; manufacturing and importation - [COVID-19: Monitoring any Shortages or Distribution Problems](https://www.eucope.org/covid-19-monitoring-any-shortages-or-distribution-problems/) - EUCOPE and its member companies are closely monitoring the COVID-19 situation and its potential impact on the manufacturing and distribution of medicinal products. EUCOPE is reporting any expected shortages or distribution problems due to the COVID-19 outbreak and/or current cross-border restrictions put in place by some EU Member States to the European Commission, the European - [Commission eyes MDR postponement by one year](https://www.eucope.org/commission-eyes-mdr-postponement-by-one-year/) - The European Commission announced on 25/03/20 that it will work to propose to the postponement of the implementation date of the Medical Devices Regulation (2017/745 - MDR). In light of the fight against COVID-19 and its numerous consequences on the healthcare systems and all actors, including industry, DG SANTE took the decision to put forward - [COVID-19: EMA New Guidances on Clinical Trials](https://www.eucope.org/covid-19-ema-new-guidances-on-clinical-trials/) - The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic. The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants, limited access to public places (including hospitals) due to the - [Fair competition for SMEs - Letter to DG SANTE](https://www.eucope.org/fair-competition-for-smes-letter-to-dg-sante/) - Following the application of the new organisation of the European Commission’s DG SANTE, EUCOPE took the opportunity to send a letter to Ms Anna-Eva Ampelas, recently appointed as Head of Unit B6 on Medical Devices, to outline our concerns on the implementation status of the Medical Devices Regulation (MDR – 2017/745) and In Vitro Diagnostics - [Guidance on Cybersecurity for Medical Devices](https://www.eucope.org/guidance-on-cybersecurity-for-medical-devices/) - The European Commission published this 06 January its guidance on cybersecurity for Medical Devices. The document, fruit of a long consultation with stakeholders including EUCOPE, provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity. The guidance can be consulted - [MDR: Second Corrigendum aims at Class 1 Devices](https://www.eucope.org/mdr-second-corrigendum-aims-at-class-1-devices/) - The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I devices an additional four years to comply. With this corrigendum, all Class I devices under the current Directive that would be up-classified - [EMA Regulatory Science Strategy: Our Proposals](https://www.eucope.org/ema-regulatory-science-strategy-our-proposals/) - As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework. - [Medical Devices: 2 New Notified Bodies ready for MDR](https://www.eucope.org/medical-devices-2-new-notified-bodies-ready-for-mdr/) - With 6 months to go before the application of the Medical Devices Regulation (MDR), the European Commission is putting pedal to metal in the implementation process! Two new Notified Bodies have indeed been recently designated to operate under MDR from May 2020. The two entities, BSI Dutch and Dare!! are based in the Netherlands and - [World Orphan Drug Congress - 12/14 November](https://www.eucope.org/world-orphan-drug-congress-12-14-november/) - The 10th World Orphan Drug Congress is taking place 12th–14th November, 2019 in Barcelona, Spain. Established as one of the largest and most established European orphan drug event, the event will propose an exciting speakers line-up and agenda covering the whole orphan drug landscape. The 12th annual event will address the strategic and commercial aspects of - [European Commission publishes options for a new EMA Fee Structure](https://www.eucope.org/european-commission-publishes-options-for-a-new-ema-fee-structure/) - Earlier this month, the European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA) together with an Inception Impact Assessment (which can be downloaded here). The latter outlines three different options on how the EMA fee system could be changed. The assessment particularly considered the question whether - [EUCOPE meeting with Maltese Health Minister](https://www.eucope.org/eucope-meeting-with-maltese-health-minister/) - Earlier this month, the Maltese Deputy Prime Minister and Minister for Health, Mr Chris Fearne, met with EUCOPE to discuss issues pertaining to transparency and access to medicines. This meeting took place against the background of the ongoing activities of the Valetta Declaration – which, inter alia, aims at exploring strategies to negotiate prices with - [1st Joint DIA-EUCOPE Workshop on ATMPs - Early Birds offers expire soon](https://www.eucope.org/1st-joint-dia-eucope-workshop-on-atmps-early-birds-offers-expire-soon/) - EUCOPE and DIA are delighted to invite you to their 1st Joint Workshop on ATMPs, Innovative Gene and Cell Therapies in the EU, taking place in Basel, Switzerland on the 29 and 30 October. This workshop will bring developers of advanced therapies to discuss a range of topics that will help them make more informed - [Medical Devices: Factsheet on UDI System](https://www.eucope.org/medical-devices-factsheet-on-udi-system/) - The European Commission just published a FAQ document on the new Unique Device Identification (UDI) system, as introduced by the two new Regulations on Medical Devices (2017/745) and In Vitro Diagnostics Devices (2017/746). The document spells out the objectives of this new system, namely to facilitate easier traceability of devices, enhance the post-market safety-related activities - [Q&A on the safety features for medicinal products on EMVO](https://www.eucope.org/qa-on-the-safety-features-for-medicinal-products-on-emvo/) - The European Commission published today an update to the Q&A document on the implementation of the rules on safety features for medicinal products for human use. The new version, completed by 3 updates and one revision, is now available on EMVO's website. More information can be found here https://emvo-medicines.eu/new/wp-content/uploads/qa_safetyfeature_en-v15.pdf. - [Doctors in Germany will be able to prescribe mobile Health applications](https://www.eucope.org/doctors-in-germany-will-be-able-to-prescribe-mobile-health-applications/) - The German Cabinet of Health adopted today (10 July) the draft of a new “digital supply law” that aims to improve access to digital health care across the country. The new law will, for instance, enable doctors to prescribe health apps that allow patients to record their blood sugar levels or blood pressure. The country’s - [The European Commission asks for new standards in line with MDR/IVDR requirements.](https://www.eucope.org/the-european-commission-asks-for-new-standards-in-line-with-mdr-ivdr-requirements/) - The European Commission is calling the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to propose revision to current standards and new ones to be in line with the coming Medical Devices and In Vitro Diagnostics Regulations' requirements. The requested focus area includ amongst others on sterilization, biological evaluation, packaging, - [EU Health Coalition calls upon the Council to increase Horizon Europe to €120 billion](https://www.eucope.org/eu-health-coalition-calls-upon-the-council-to-increase-horizon-europe-to-e120-billion/) - In a public statement, the EU Health Coalition (a group of 28 stakeholders from patient groups, research organisations and the pharmaceutical industry), calls the Council to increase Horizon Europe to €120 billion, ahead of their discussions on the Multiannual Financial Framework. Echoing the proposal from the European Parliament, the Coalition asks for a robust budget - [Brexit: EC Communication on Contingency Measures](https://www.eucope.org/brexit-ec-communication-on-contingency-measures/) - The European Commission published on the 12 June its 5th state-of-play communication on the preparation of contingency measures for the withdrawal of the United Kingdom from the European Union (Brexit). In its 10-page document, the Commission reiterates its recommendation for a high level of preparedness across all sectors to mitigate the negative impact of a - [Speeding Up Access in the UK – the Accelerated Access Collaborative Program](https://www.eucope.org/speeding-up-access-in-the-uk-the-accelerated-access-collaborative-program/) - New improvements to the Accelerated Access Collaborative (AAC) will aim to put the most promising medicines, diagnostics, and digital services through the clinical development and regulatory approval process faster. The AAC was set up in 2018 as a fast-track route into the NHS for breakthrough medicines and technologies. The scheme will now become the new - [Event 18/09: Performance-Driven Payments in Europe](https://www.eucope.org/event-18-09-performance-driven-payments-in-europe/) - We would like to make you aware of an event chaired by EUCOPE Secretary General Alexander Natz which looks from various angles at innovative payment models in the UK, BeNeLuxAI, Italy and Germany. Speakers include, inter alia, Dr Diane Kleinermans, Ministry of Public Health and Social Security, Belgium Sheela Upadhyaya, National Institute for Health and - [MDR: EUCOPE's concern shared in latest Politico report](https://www.eucope.org/mdr-eucopes-concern-shared-in-latest-politico-report/) - With almost one year to go before the implementation of the Medical Devices Regulation (MDR) 2017/745, the Brussels-based edition of Politico reports on the main problems for related stakeholders, whilst the European Commission is scrambling to get things in order before May 2020. Representing EUCOPE in his capacity of co-chair of our Regulatory and Medical - [France Biotech HealthTech Investor Day – 24/25 June, Paris](https://www.eucope.org/france-biotech-healthtech-investor-day-24-25-june-paris/) - France Biotech, with the help of the European health innovation ecosystem, is organising a HealthTech Investor Day in Paris on 24/25 June 2019. This European business event aims to connect leading investors (European, American and Asian), pharmaceuticals companies and C-level executives from European innovative companies in HealthTech (biotech, medtech and e-health). Bringing together private and - [EMA Regulatory Science Strategy 2025](https://www.eucope.org/ema-regulatory-science-strategy-2025/) - You still have a bit more than one month to contribute to the EMA's next strategy for regulatory science! The European Medicines Agency (EMA) is indeed seeking views from stakeholders, partners and the general public on its proposed strategy on Regulatory Science to 2025. By highlighting where stakeholders see the need as greatest, you have - [MAP BioPharma Report on access to OMPs in the UK](https://www.eucope.org/map-biopharma-report-on-access-to-omps-in-the-uk/) - Our member MAP BioPharma recently put forward a series of recommendations focused on UK’s appraisals and reimbursement processes, in their latest publication titled Access to Orphan Medicines: A Case for Change. The report shows that: Very small differences between treatments in terms of patient numbers or clinical management can have a significant impact on the criteria - [EC Gets Ready for a No Deal Brexit](https://www.eucope.org/ec-gets-ready-for-a-no-deal-brexit/) - In the event the United Kingdom leaves the EU without a deal, access to medicines may be affected and to alleviate any doubts, the EMA has published a questions & answers document on the preparatory work to prevent medicine shortages. If at any point in time a specific shortage is confirmed for a medicine, this - [MDR & IVDR Implementation Rolling Plan - Latest Update](https://www.eucope.org/mdr-ivdr-implementation-rolling-plan-latest-update/) - Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting of 14 February, the European Commission (EC) updated the ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play of the coming Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). - [Pricing & Reimbursement processes of Orphan Medicinal Products diverge from the ORPH-VAL principles](https://www.eucope.org/pricing-reimbursement-processes-of-orphan-medicinal-products-diverge-from-the-orph-val-principles/) - A report, commissioned by EUCOPE points out the uneven alignment of Pricing & Reimbursement (P&R) systems in five European countries with the 2015 ORPH-VAL Principles. Back in 2015, in an effort to improve consistency in P&R processes for Orphan Medicinal Products (OMPs) and avoid delays in treating patients, the ORPH-VAL Working Group, which comprised multiple - [Gene & Cell Therapy: From Discovery to Access - Event](https://www.eucope.org/gene-cell-therapy-from-discovery-to-access-event/) - EUCOPE, together with SME Connect and SME Europe is organising an event at the European Parliament on the opportunities and challenges of gene and cell therapies - 05 March. Entitled 'From Discovery to Access: How can we ensure Europe is at the forefront of innovation and access delivery of gene and cell therapies', the event - [Germany Agrees on New Pharmaceutical Bill](https://www.eucope.org/germany-agrees-on-new-pharmaceutical-bill/) - On 30 January, the German government has agreed on a draft Act for more safety in the supply of pharmaceuticals (“GSAV”). Although the wording of the original bill has been amended since it was released by the Ministry of Health last year, it still contains provisions that would have a significant impact on, inter alia, - [Position Paper on Gene & Cell Therapies - Game-changer solutions ?](https://www.eucope.org/position-paper-on-gene-cell-therapies-game-changer-solutions/) - Gene & Cell therapies have arrived, and bring with them important challenges. Our Task Force, including some of our members active in gene and cell therapies, have worked on a position paper addressing some important questions raised by these novel techniques. The paper sets out our take on HTA and evidential options Funding solutions Patient - [Falsified Medicines in the EU: New Features for Better Patient Safety](https://www.eucope.org/falsified-medicines-in-the-eu-new-features-for-better-patient-safety/) - New safety features for medicines in the EU: An improved better safety, and measures against falsified medicines. - [EURORDIS Multi-stakeholder Symposium, 13-14 February, Brussels](https://www.eucope.org/eurordis-multi-stakeholder-symposium-13-14-february-brussels/) - EURORDIS, the non-profit alliance representing rare diseases patient organisations will organise its 3rd Multi-Stakeholder Symposium on Improving Patients’ Access to Rare Disease Therapies on 13-14 February 2019 in Brussels, Belgium. The event will bring together stakeholders from various backgrounds to discuss sustainable solutions to improve patients’ access to rare disease therapies. Ahead of the symposium, - [Invitation - Inside the Minds of Regulators: Perspectives on EU Pharmaceutical & Medical Devices Law](https://www.eucope.org/invitation-inside-the-minds-of-regulators-perspectives-on-eu-pharmaceutical-medical-devices-law/) - EUCOPE, in collaboration with its member Sidley, as well as Navitas and PWC, is organising a conference on the 21st of February in Brussels, to discuss recent developments in pharma and medical devices law. The event will bring together senior and former members of the European Commission, the European Medicines Agency (EMA), the Dutch Medicines - [EMA Public Consultation on Patient Registries](https://www.eucope.org/public-consultation-on-patient-registries/) - The European Medicines Agency (EMA) has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is - [Changes in sight for OMPs and biosimilars in Germany?](https://www.eucope.org/changes-in-sight-for-omps-and-biosimilars-in-germany/) - The German Ministry of Health recently released a draft bill proposal that would introduce significant changes to the legislation on Orphan Medicinal Products (OMPs) and biosimilars in Germany. The bill, which has yet to pass the Cabinet for approval, sets out plans for mandatory registries for OMPs and Marketing Authorisations under conditional approval or exceptional - [Brexit: Is long-term cooperation on health in jeopardy?](https://www.eucope.org/brexit-is-long-term-cooperation-on-health-in-jeopardy/) - In a letter addressed to Martin Selmayr, European Commission Secretary General, the European health community - patients, researchers, pharmaceutical companies - raised its concerns about the lack of contingency measures specific to the continued collaboration on health and asks for an epxlicit commitment from both parties to long-term cooperation around public health, the regulation and - [The European Commission publishes a 'Rolling Plan' for MDR & IVDR Regulations](https://www.eucope.org/the-european-commission-publishes-a-rolling-plan-for-mdr-ivdr-regulations/) - the European Commission (EC) published a ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play - [Joint policy document on the potential impact of the UK’s exiting the EU by the associations representing the European and British life science industry](https://www.eucope.org/joint-policy-document-on-the-potential-impact-of-the-uks-exiting-the-eu-by-the-associations-representing-the-european-and-british-life-science-industry/) - The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launched a joint policy document on the potential impact of the United Kingdom’s exiting the European Union. Abstract The life science industry is highly integrated across Europe and regulated - [Associations representing the European and British life science industry respond to the European Council approving terms of the transition period agreed between the UK Government and EU](https://www.eucope.org/associations-representing-the-european-and-british-life-science-industry-respond-to-the-european-council-approving-terms-of-the-transition-period-agreed-between-the-uk-government-and-eu/) - The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today responded to the European Council approving terms of the transition period agreed between the UK Government and EU. Statement in response to the EU Council ratifying the Brexit transition - [Better regulation, SMEs and intellectual property: there is work to be done!](https://www.eucope.org/better-regulation-smes-and-intellectual-property-there-is-work-to-be-done/) - On 13 March 2018, EUCOPE co-organised with Comitology.eu a breakfast discussion on “Future proofing EU policies for SMEs – a Case Study on Intellectual Property Rights”. Attended by over 30 commercial and institutional stakeholders as well as press and academia, the breakfast discussion touched upon the impact of SMEs on the actual EU decision and - [Brexit: deal or no deal, the health of European patients must not suffer](https://www.eucope.org/sample-post-for-eucope-news-member-news/) - With the Brexit clock ticking, both sides are now preparing for a possible ’no deal’ Brexit, which could impact on patient and public health across the EU27. The European health community will express their concern that with time running out, no substantial progress has been made on those areas affecting patient and public health at - [European health community calls on the EU and UK to prioritise patients as crunch Article 50 decision approaches](https://www.eucope.org/european-health-community-calls-on-the-eu-and-uk-to-prioritise-patients-as-crunch-article-50-decision-approaches-2/) - Today a group of organisations representing patients, healthcare professionals and the health care industry have called on the EU and UK to prioritise patients in the Brexit negotiations. To coincide with the EPSCO Council of EU Health Ministers in Brussels, this policy statement comes just one week ahead of the crunch European Council meeting where - [EUCOPE and other associations representing the European and British life science industry launch a joint policy document on the potential impact of the UK’s exiting the EU](https://www.eucope.org/eucope-and-other-associations-representing-the-european-and-british-life-science-industry-launch-a-joint-policy-document-on-the-potential-impact-of-the-uks-exiting-the-eu/) - The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launched a joint policy document on the potential impact of the United Kingdom’s exiting the European Union. Today, organisations representing the life science industry in the EU and the - [European health community calls on the EU and UK to prioritise patients as crunch Article 50 decision approaches](https://www.eucope.org/european-health-community-calls-on-the-eu-and-uk-to-prioritise-patients-as-crunch-article-50-decision-approaches/) - Today a group of organisations representing patients, healthcare professionals and the health care industry have called on the EU and UK to prioritise patients in the Brexit negotiations. To coincide with the EPSCO Council of EU Health Ministers in Brussels, this policy statement comes just one week ahead of the crunch European Council meeting where - [Joint policy document on the potential impact of the UK’s exiting the EU by the associations representing the European and British life science industry](https://www.eucope.org/joint-policy-document-on-the-potential-impact-of-the-uks-exiting-the-eu/) - The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) have today launched a joint policy document on the potential impact of the United Kingdom’s exiting the European Union. Abstract The life science industry is highly integrated across Europe and regulated ## Pages - [EUCOPE Home Page](https://www.eucope.org/) - EUCOPE is Europe’s trade body for small to mid-sized innovative companies working in the field of biopharmaceuticals and medical technologies. - [Our Team - Secretariat & Board](https://www.eucope.org/people/) - Our people in Brussels provide expertise in legal, public policy and government affairs in the world of pharmaceuticals, biotech and medical technologies. - [Rare Disease Hub](https://www.eucope.org/rare-disease-hub/) - Find all of the latest news regarding our activities on rare diseases, orphan medicinal products (OMPs) and the rare diseases community. - [Get in Touch](https://www.eucope.org/contact/) - Thank you for contacting us, please fill in the form here below and we will get back to you as soon as possible. For Press Inquiries - click here. - [Our Partnerships](https://www.eucope.org/our-partnerships/) - We believe that policy solutions need to be devised all along the lifecycle of medicines, from very early research to patient access. - [Frequently Asked Questions (FAQ) about ECGP](https://www.eucope.org/european-coalition-for-comprehensive-genomic-profiling-ecgp/frequently-asked-questions-ecgp/) - Frequently Asked Questions (FAQs) about the European Coalition for Access to Comprehensive Genomic Profiling (ECGP). - [Our Work](https://www.eucope.org/our-work/) - With our members, we analyse, monitor and engage several topics and themes in our Working Groups, Steering Groups, Task Forces and Partner Networks. - [Frequently Asked Questions (FAQs) | EUCOPE Membership](https://www.eucope.org/members/eucope-membership-faqs/) - For more information on how the application process, membership costs and benefits, please refer to our Frequently Asked Questions (FAQs). - [Benefits of EUCOPE Membership](https://www.eucope.org/members/benefits-of-eucope-membership/) - As a watchdog for EU biopharma legislation, we help innovative companies navigate Europe with a targeted focus on market access, innovation and rare diseases. - [European Coalition for Access to Comprehensive Genomic Profiling (ECGP)](https://www.eucope.org/european-coalition-for-comprehensive-genomic-profiling-ecgp/) - The ECGP was launched to improve cancer care through increased routine clinical access and reimbursement of Comprehensive Genomic Profiling (CGP). - [About Us](https://www.eucope.org/about-us/) - The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the voice of small to mid-sized health technology companies in Europe. - [Our Members](https://www.eucope.org/members/) - EUCOPE represents small to medium-sized companies that support, invest and produce the innovative medicines and therapies of the future. - [Resources](https://www.eucope.org/resources/) - Below you will find a list of our resources (position papers, reports, statements, webinars etc) related to our main priorities and working groups. - [Imprint and Disclaimer](https://www.eucope.org/imprint-and-disclaimer/) - Content EUCOPE AISBL reserves the right not to be responsible for the topicality, correctness, completeness or quality of the information provided. Liability claims regarding damage caused by the use of any information provided, including any kind of information which is incomplete or incorrect,will therefore be rejected. All offers are not-binding and without obligation. Parts of - [EUCOPE Calendar of Events](https://www.eucope.org/events/) - All of the upcoming events and meetings in the EUCOPE world. - [Pulling out all the stops to deliver high-quality care for European cancer patients](https://www.eucope.org/cancerconferenceeu/) - Welcome to the virtual conference hosted by EUCOPE and BPI on Europe’s Beating Cancer plan! About the conference Earlier this year the European Commission published their ‘Europe’s Beating Cancer Plan’ which aims to reduce the cancer burden for patients, their families and health systems. The plan, which represents the largest EU initiative on cancer since - [Pharmaceutical Strategy for Europe](https://www.eucope.org/pharmaceutical-strategy-for-europe/) - Adopted on 25 November 2020, the European Commission proposal for Pharmaceutical Strategy for Europe aims at creating a future proof regulatory framework and at supporting industry in promoting research and technologies that actually reach patients in order to fulfil their therapeutic needs while addressing market failures. This ambitious initiative has the potential to modify the - [Gene & Cell Therapies - Q&A](https://www.eucope.org/gene-cell-therapies-qa/) - [Your Health - Bringing Solutions to Patients](https://www.eucope.org/health/) - The past years have seen tremendous progress in biopharmaceutical research and medical technologies, bringing solutions to patients all over the EU. This is particularly true in the domain of rare diseases. This is thanks to a combination of science and incentives to develop medicinal products for patients and the industry’s relentless dedication to increasing the - [Privacy policy](https://www.eucope.org/data-privacy/) - General Remarks EUCOPE values the protection and confidentiality of your personal data. EUCOPE processes data in accordance with its responsibilities under the General Data Protection Regulation (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016). The following information provides a simple overview of how we process your personal data. ## Events - [EUCOPE's Life Science Lectures - Webinar Episode Two](https://www.eucope.org/events/eucopes-life-science-lectures-webinar-episode-two/) - On the second episode, we will talk about the definitions of unmet medical need (UMN) and high UMN (HUMN) within the EU Pharmaceutical Package. - [TRANSFORM in France: EU - a space for R&D in cell & gene therapies?](https://www.eucope.org/events/transform-in-france-eu-a-space-for-rd-in-cell-gene-therapies/) - TRANSFORM will host a roundtable to exchange on the ATMP landscape in France, and the potential impact of the Pharma Package on access to ATMPs in Member States - [Looking ahead to the upcoming Spanish EU Council Presidency](https://www.eucope.org/events/looking-ahead-to-the-upcoming-spanish-eu-council-presidency/) - You are warmly invited to an APCO Forum event on the upcoming Spanish Presidency of the Council of the EU. - [#BreakTheBubble - "Does Europe really want to foster #innovation in life sciences?"](https://www.eucope.org/events/breakthebubble-does-europe-really-want-to-foster-innovation-in-life-sciences/) - We are delighted to take part in the upcoming breakfast debate "Does Europe really want to foster #innovation in life sciences?" by Evoke Incisive Health. - [Pharmaceutical Legislation Task Force](https://www.eucope.org/events/pharmaceutical-legislation-task-force-3/) - This meeting is open to EUCOPE Members only. For further information, please contact Stefano Romanelli. - [OMP Working Group](https://www.eucope.org/events/omp-working-group-5/) - This meeting is open to EUCOPE Members only. For further details, please contact Victor Maertens. - [Health Crisis Management & Preparedness Steering Group](https://www.eucope.org/events/health-crisis-management-preparedness-steering-group-meeting-4/) - This meeting is for EUCOPE members only. For further details please contact Guilherme Ursini. - [Clinical Trials Focus Group](https://www.eucope.org/events/clinical-trials-focus-group/) - This meeting is open to EUCOPE Members only. For further details, please contact Guilherme Ursini. - [AMR SG](https://www.eucope.org/events/amr-sg/) - This meeting is open to EUCOPE Members only. For further information, please contact Stefano Romanelli. - [Regulatory Working Group](https://www.eucope.org/events/regulatory-working-group-2/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [OMP Working Group](https://www.eucope.org/events/omp-working-group-4/) - This meeting is open to EUCOPE Members only. For further details, please contact Victor Maertens. - [Biotech Subgroup](https://www.eucope.org/events/biotech-subgroup/) - This meeting is open to EUCOPE Members only. For further information, please contact Stefano Romanelli. - [Quality Innovation Focus Group](https://www.eucope.org/events/quality-innovation-focus-group/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [Regulatory Digitalisation Focus Group](https://www.eucope.org/events/regulatory-digitalisation-focus-group/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [Environmental & Sustainability Working Group](https://www.eucope.org/events/environmental-sustainability-wg/) - This meeting is open to EUCOPE Members only. For further information, please contact Guilherme Ursini. - [Regulatory Working Group](https://www.eucope.org/events/regulatory-working-group-4/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [Quality Innovation Focus Group](https://www.eucope.org/events/quality-innovation-focus-group-3/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [Pharmacovigilance Focus Group](https://www.eucope.org/events/pharmacovigilance-focus-group-2/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [Regulatory Digitalisation Focus Group](https://www.eucope.org/events/regulatory-digitalisation-focus-group-3/) - This meeting is open to EUCOPE Members only. For further information, please contact Marta Provencio. - [AMR SG](https://www.eucope.org/events/amr-sg-2/) - This meeting is open to EUCOPE Members only. For further information, please contact Stefano Romanelli. - [Regulatory Working Group](https://www.eucope.org/events/regulatory-working-group-3/) - This meeting is open the EUCOPE Members only. For further information, please contact Marta Provencio. - [Quality Innovation Focus Group](https://www.eucope.org/events/quality-innovation-focus-group-2/) - This meeting is open to EUCOPE Members only. For further details, please contact Marta Provencio. - [Regulatory Digitalisation Focus Group](https://www.eucope.org/events/regulatory-digitalisation-focus-group-2/) - This meeting is open to EUCOPE Members only. For further details, please contact Marta Provencio. - [Pharmacovigilance Focus Group](https://www.eucope.org/events/pharmacovigilance-focus-group/) - This meeting is open to EUCOPE Members only. For further details, please contact Marta Provencio. - [AMG SG](https://www.eucope.org/events/amg-sg/) - This meeting is open to EUCOPE Members only. For further details, please contact Stefano Romanelli. - [Medical Technologies Focus Group](https://www.eucope.org/events/medical-technologies-focus-group/) - This meeting is open to EUCOPE Members only. For further details, please contact Marta Provencio. - [Environment & Sustainability Working Group](https://www.eucope.org/events/environment-sustainability-wg/) - This meeting is for Members only. In case of interest, please contact Guilherme Ursini. - [Cell & Gene Therapy Working Group Meeting](https://www.eucope.org/events/eucope-cell-gene-therapy-working-group-meeting-3/) - This meeting is open to EUCOPE Members only. For further information please reach out to Serena Rama. - [Health Crisis Management & Preparedness Steering Group Meeting](https://www.eucope.org/events/health-crisis-management-preparedness-steering-group-meeting-3/) - This meeting is for EUCOPE members only. For further details, please contact Guilherme Ursini. - [EUCOPE Legal Meeting](https://www.eucope.org/events/eucope-legal-meeting-2/) - This meeting will take place in-person in Zurich. For further details and registration, please contact Matthias Heck. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-8/) - Open to EUCOPE Members. - [Biotech Subgroup](https://www.eucope.org/events/biotech-subgroup-2/) - This meeting is for Members only. In case of interest, please contact Stefano Romanelli. - [Pharmaceutical Legislation Task Force](https://www.eucope.org/events/pharmaceutical-legislation-task-force-2/) - This meeting is for Members only. In case of interest, please contact Stefano Romanelli. - [Pharmaceutical Legislation Task Force](https://www.eucope.org/events/pharmaceutical-legislation-task-force/) - This meeting is for Members only. In case of interest, please contact Stefano Romanelli. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-9/) - Further information to follow. - [OMP Working Group](https://www.eucope.org/events/omp-working-group-3/) - This is for EUCOPE members only. For meeting details or the agenda, please contact Victor Maertens. - [EUCOPE Members Townhall on the General Pharma Legislation (GPL)](https://www.eucope.org/events/eucope-members-townhall-on-the-general-pharma-legislation-gpl/) - This meeting is for EUCOPE members only. For further details, please contact Victor Maertens and Stefano Romanelli. - [P&R / Market Access Working Group](https://www.eucope.org/events/pr-market-access-working-group-2/) - This meeting is open to EUCOPE members only. For meeting details or the agenda, please reach out to Matias Olsen. - [Cell & Gene Therapy Working Group Meeting](https://www.eucope.org/events/eucope-cell-gene-therapy-working-group-meeting-2/) - This meeting is open to EUCOPE members only. For further information please contact Serena Rama. - [Cell & Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-gene-therapy-working-group-meeting/) - This meeting is open to EUCOPE members only. For further information please reach out to Serena Rama. - [EUCOPE Cell & Gene Therapy Working Group Meeting](https://www.eucope.org/events/eucope-cell-gene-therapy-working-group-meeting/) - This meeting is open to EUCOPE members only. For further information please reach out to Serena Rama. - [EUCOPE Webinar - Economic Footprint Study](https://www.eucope.org/events/eucope-webinar-economic-footprint-study/) - EUCOPE published the results of our Economic Footprint Study. We will discuss the outcomes in a Webinar which is open to the public. Registration is possible here. - [Health Crisis Management & Preparedness Steering Group Meeting](https://www.eucope.org/events/health-crisis-management-preparedness-steering-group-meeting-2/) - This is for EUCOPE members only. For further details please contact Guilherme Ursini. - [Health Crisis Management & Preparedness Steering Group Meeting](https://www.eucope.org/events/health-crisis-management-preparedness-steering-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Guilherme Ursini. - [3rd EUCOPE HTA Workshop](https://www.eucope.org/events/3rd-eucope-hta-workshop/) - In-person event for senior leaders in pharmaceutical companies. For participation please contact Saskia Jansen. - [Regulatory Working Group](https://www.eucope.org/events/regulatory-working-group/) - For further information, please contact Marta Provencio. - [EUCOPE Legal Meeting](https://www.eucope.org/events/eucope-legal-meeting/) - This meeting will take place in person in Zurich. For further information and registration, please contact Matthias Heck. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-7/) - For further information, please contact Saskia Jansen. - [OMP Working Group](https://www.eucope.org/events/omp-working-group-2/) - Exchange with RDI. For further information, please contact Victor Maertens. - [EUCOPE Biotech Act Townhall](https://www.eucope.org/events/eucope-biotech-act-townhall/) - EUCOPE will host a virtual Townhall meeting. The meeting is open to EUCOPE members. For further information, please contact Stefano Romanelli. - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-7/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor (Maertens@eucope.org). - [Health Crisis Management & Preparedness Steering Group](https://www.eucope.org/events/health-emergency-preparedness-and-response-hera-steering-group-3/) - This is for EUCOPE members only. For further information, please contact Guilherme (Ursini@eucope.org). - [Digital Health & AI Working Group](https://www.eucope.org/events/digital-health-ai-wg/) - This is for EUCOPE members only. For further information contact Leander (Vranken@eucope.org). - [Pricing & Reimbursement/ Market Access Working Group](https://www.eucope.org/events/pricing-reimbursement-market-access-working-group-2/) - This is for EUCOPE members only. For further information, please contact Matias (Olsen@eucope.org). - [Environment and Sustainability Working Group](https://www.eucope.org/events/environment-and-sustainability-working-group/) - This is for EUCOPE members only. For further information, please contact Guilherme (Ursini@eucope.org). - [2nd EU HTA Workshop](https://www.eucope.org/events/2nd-eu-hta-workshop/) - In-person event for senior leaders in pharmaceutical companies. For participation please contact Saskia Jansen. - [Cell and Gene Therapy Working Group](https://www.eucope.org/events/cell-and-gene-therapy-working-group-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Cell and Gene Therapy Working Group](https://www.eucope.org/events/cell-and-gene-therapy-working-group-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [EUCOPE Legal Working Group](https://www.eucope.org/events/eucope-legal-working-group/) - The Legal Working Group will meet on 7 October 2025 in Zurich. For participation in the in-person meeting and further information, please contact Matthias Heck. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-6/) - This meeting is for EUCOPE Members only. For meeting details or the agenda, please contact Saskia Jansen. EUCOPE Members Meeting. - [BIO International Convention 2025](https://www.eucope.org/events/bio-international-convention-2025/) - EUCOPE will be speaking at the following panels: "Breaking Through: Overcoming Early Development Challenges" Monday, June 16 | 13:45 – 14:45 (Boston time) "Navigating Barriers: The Journey of a Molecule to the Marketplace" Tuesday, June 17 | 12:15 – 13:30 (Boston time) "EU Policy: Evolution or Revolution for Biotech?" Thursday, June 18 | 9:00 – - [European Healthcare & Life Sciences Investor Symposium](https://www.eucope.org/events/european-healthcare-life-sciences-investor-symposium-2/) - Join the European Healthcare & Life Sciences Investor Symposium in Paris for insightful discussions on top strategies in an ever-changing life sciences market. - [Implementing the European Health Data Space (EHDS): The Next Steps](https://www.eucope.org/events/implementing-the-european-health-data-space-ehds-the-next-steps/) - Join EUCOPE on 6 May 2025 for an insightful and dynamic webinar on the next steps in implementing the European Health Data Space (EHDS) Regulation. - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-5/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [EUCOPE Workshop | How to Prepare for EU HTA from a Payer Perspective](https://www.eucope.org/events/eucope-workshop-how-to-prepare-for-eu-hta-from-a-payer-perspective/) - EUCOPE invites senior executives and decision-makers in the pharmaceutical industry to an in-person workshop on EU HTA on 8 May 2025. - [World Orphan Drug Congress USA 2025](https://www.eucope.org/events/world-orphan-drug-congress-usa-2025/) - EUCOPE is participating in the World Orphan Drug Congress in Boston, on 23 and 24 April 2025. - [Advanced Therapies Congress 2025](https://www.eucope.org/events/advanced-therapies-congress-2025/) - EUCOPE invites you to the Advanced Therapies Conference on 18 and 19 2025 March in London. - [Real World Data/Evidence Working Group Meeting](https://www.eucope.org/events/real-word-data-evidence-working-group-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [Cell and Gene Therapy Working Group](https://www.eucope.org/events/cell-and-gene-therapy-working-group/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens or Stefania Alessi. - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-6/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Preparing for EU HTA Joint Clinical Assessments and Joint Scientific Consultations – Practical information to navigate the new procedures](https://www.eucope.org/events/preparing-for-eu-hta-joint-clinical-assessments-and-joint-scientific-consultations-practical-information-to-navigate-the-new-procedures/) - Join our very own experts Alexander Natz and Matias Olsen on Wednesday 15 January, for a one-hour session to better understand new requirements - [EUCOPE - Sidley Life Science College (LSC)](https://www.eucope.org/events/eucope-sidley-life-science-college-lsc/) - Join EUCOPE and Sidley for the annual Life Sciences College (LSC), a day of in-depth discussions on cutting-edge trends with regulators from the European Commission (including overall pharmaceutical policy, DG COMP, and EHDS), reimbursement authorities (G-BA), investors, and industry leaders. LSC is an exclusive opportunity to engage with regulators to discuss legal and policy issues. Find out - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-5/) - This meeting is for EUCOPE Members only. For meeting details or the agenda, please contact Saskia Jansen. - [Health Emergency Preparedness and Response (HERA) – Steering Group](https://www.eucope.org/events/health-emergency-preparedness-and-response-hera-steering-group-2/) - This meeting is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [Medical Technologies Focus Group (MDR, IVDR & DDC)](https://www.eucope.org/events/medical-technologies-focus-group-mdr-ivdr-ddc-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [Cell and Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-and-gene-therapy-working-group-meeting-5/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens or Stefania Alessi. - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Health Emergency Preparedness and Response (HERA) - Steering Group](https://www.eucope.org/events/health-emergency-preparedness-and-response-hera-steering-group/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [TEHDAS2 stakeholder forum](https://www.eucope.org/events/tehdas2-stakeholder-forum/) - The European Health Data and Innovation Summit is an event on the future of healthcare, focusing on the use of health data and innovative technologies. - [EU Health Summit 2025: Reshaping health for a stronger Europe](https://www.eucope.org/events/eu-health-summit-2025-reshaping-health-for-a-stronger-europe/) - On Tuesday 28 January 2024, join the EUCOPE team at the EU Health Summit and help shape a roadmap for a healthier Europe, at Sparks, in Brussels - [Together 4 Rare Diseases and ERICA Joint Webinar on European Reference Networks](https://www.eucope.org/events/together-4-rare-diseases-and-erica-joint-webinar-on-european-reference-networks/) - A joint webinar hosted by Together 4 Rare Diseases and ERICA, the European Rare Disease Research Coordination and Support Action consortium. This webinar will provide a comprehensive overview of ERNs’ core mission within the European healthcare landscape, detailing the resources, expertise, and infrastructure ERNs offer, and illustrating how collaborations between ERNs and the private sector - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting-6/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [Pricing & Reimbursement/Market Access Working Group](https://www.eucope.org/events/pricing-reimbursement-market-access-working-group/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Bio-neuroscience](https://www.eucope.org/events/bio-neuroscience/) - Bio-Neuroscience convenes innovators, CEOs and decision-makers in CNS neuroscience drug development from the leading biotech companies. - [ISPOR "Missed Signals: The Economic Implications of Current Health Technology Assessment Protocols for Diagnostics"](https://www.eucope.org/events/ispor-missed-signals-the-economic-implications-of-current-health-technology-assessment-protocols-for-diagnostics/) - This symposium aims to delve into the methodologies, processes, and results related to HTA assessment specifically for diagnostic imaging technologies. - [EU policy to secure safe and timely access to advanced therapies for patients](https://www.eucope.org/events/eu-policy-to-secure-safe-and-timely-access-to-advanced-therapies-for-patients/) - On 21 November join the TRANSFORM conference: Relaunch of the MEP Interest Group: EU policy to secure safe and timely access to advanced therapies for patients. - [The Economic Lens: Unveiling What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package](https://www.eucope.org/events/the-economic-lens-unveiling-what-drives-life-sciences-investment-in-the-eu-and-the-future-impact-of-the-pharma-package/) - EUCOPE & FTI presenthe report: 'The Economic Lens: Unveiling What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package' - [Paediatric Focus Group meeting](https://www.eucope.org/events/paediatric-focus-group/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefania Alessi. - [Pendulum: Patient-centered and future-oriented care for rare diseases in Germany](https://www.eucope.org/events/pendulum-patient-centered-and-future-oriented-care-for-rare-diseases-in-germany/) - On 26 November, Chiesi Deutschland will host a multi-stakeholder discussion on the burden of care for rare diseases and the economic impact on German citizens - [World Orphan Drug Congress Europe 2024](https://www.eucope.org/events/world-orphan-drug-congress-europe-2024/) - The World Orphan Drug Congress Europe is the largest and most established orphan drug & rare disease event worldwide. Meet over 2000 attendees, hear from 250 leading speakers, and connect with 130 exhibitors as we bring together experts from the start-to-finish of orphan drugs. From regulation and policy to global pricing and gene therapy, the - [EUCOPE's Life Sciences Lectures - Episode Eight](https://www.eucope.org/events/eucopes-life-sciences-lectures-episode-eight/) - EUCOPE's webinar on the European Health Data Space (EHDS), aiming to transform healthcare data management and accessibility for research & innovation across EU - [European Healthcare & Life Sciences Investor Symposium](https://www.eucope.org/events/european-healthcare-life-sciences-investor-symposium/) - This event is an opportunity for decision-makers across the healthcare and life sciences investment ecosystem to connect and stay informed in thisspace. - [EUCOPE’s Life Science Lectures – Episode Seven](https://www.eucope.org/events/eucopes-life-science-lectures-episode-seven/) - EUCOPE will provide a rundown on new EU HTA procedure for European market launch. The requirements apply to all oncology products and ATMPs from 12 January 2025 - [P&R / Market Access Working Group Meeting](https://www.eucope.org/events/pr-market-access-working-group-meeting-5/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [EU HTA Task Force Meeting](https://www.eucope.org/events/eu-hta-task-force-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting-6/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [EUCOPE’s Life Science Lectures – Episode Six](https://www.eucope.org/events/eucopes-life-science-lectures-episode-six/) - Healthcare access across national borders has been an issue for people with rare diseases. Panelists will explore how to improve cross-border deliver of ATMPs - [World EPA Congress 2025](https://www.eucope.org/events/world-epa-congress-2025/) - Join the World Evidence, Pricing and AccessCongress 2025 on 5-6 March in Amsterdam, discussing market access, pricing and evidence - [EUCOPE’s Life Science Lectures – Episode Five](https://www.eucope.org/events/the-new-eu-hta-procedure-how-can-jcas-support-access-to-omps-for-people-living-with-rare-diseases/) - Panelists discuss challenges in evidence generation for OMPs, draw on clinical and national HTA experiences, explore approaches to ensure JCAs speed up access - [Pricing & Reimbursement/Market Access Working Group Meeting](https://www.eucope.org/events/pricing-reimbursement-market-access-working-group-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Medical Technologies Focus Group (MDR, IVDR & DDC)](https://www.eucope.org/events/medical-technologies-focus-group-mdr-ivdr-ddc-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [EU HTA Task Force Meeting](https://www.eucope.org/events/eu-hta-task-force-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Genomics Working Group Meeting](https://www.eucope.org/events/genomics-working-group-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [HERA Steering Group Meeting](https://www.eucope.org/events/hera-steering-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [EUCOPE Townhall meeting](https://www.eucope.org/events/eucope-townhall-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [Clinical Trials Focus Group meeting](https://www.eucope.org/events/clinical-trials-focus-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting-5/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [Medical Technologies Focus Group (MDR, IVDR & DDC)](https://www.eucope.org/events/medical-technologies-focus-group-mdr-ivdr-ddc/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [Pharmacovigilance Focus Group Meeting](https://www.eucope.org/events/pharmacovigilance-focus-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [Paediatric Focus Group meeting](https://www.eucope.org/events/paediatric-focus-group-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefania Alessi. - [Cell and Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-and-gene-therapy-working-group-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor or Stefania. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Saskia Jansen. - [Cell and Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-and-gene-therapy-working-group-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting-5/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [World Orphan Drug Congress US 2024](https://www.eucope.org/events/world-orphan-drug-congress-us-2024/) - The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies. Join for three days in Boston for the most comprehensive - [EU HTA Task Force Meeting](https://www.eucope.org/events/eu-hta-task-force-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Webinar: Rare Paediatric Neurological Diseases: A Focus on Europe](https://www.eucope.org/events/webinar-rare-paediatric-neurological-diseases-a-focus-on-europe/) - PTC Therapeutics invites you to participate in a webinar to present the findings of the report ‘Rare paediatric neurological diseases: A focus on Europe’ - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [Cell and Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-and-gene-therapy-working-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor or Stefania. - [RARE DISEASES FORUM 2024: Securing Europe’s competitiveness in R&D for people living with rare diseases](https://www.eucope.org/events/rare-diseases-forum-2024-securing-europes-competitiveness-in-rd-for-people-living-with-rare-diseases/) - Against the backdrop of the Belgian EU Council Presidency, the forum will bring together senior leaders from across patient organisations, industry and policy to address how and why innovation in tackling rare diseases can support the EU’s competitiveness agenda and strengthen the case for EU Action on Rare Diseases. Confirmed speakers include Yann Le Cam, CEO - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Seán Byrne. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-3/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Saskia Jansen. - [Cell and Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-and-gene-therapy-working-group-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Victor Maertens. - [Paediatric Focus Group Meeting](https://www.eucope.org/events/paediatric-focus-group-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefania Alessi. - [EU HTA Task Force Meeting](https://www.eucope.org/events/eu-hta-task-force-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [DIA Europe 2024 - Collaborating for Healthcare Innovation – a focus on Sustainability!](https://www.eucope.org/events/dia-europe-2024-collaborating-for-healthcare-innovation-a-focus-on-sustainability/) - DIA Europe 2024 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2024 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role - [Europe Rare Disease Summit 2024](https://www.eucope.org/events/europe-rare-disease-summit-2024/) - The European Rare Disease Summit aims to explore important developments and issues in diagnosing and treating Rare Diseases in Europe. This will be done through a series of discussions and individual talks led by experts in the field. The event will also address the obstacles faced in ensuring prompt and fair availability of specialized medications, - [Medical Technologies Focus Group Meeting](https://www.eucope.org/events/medical-technologies-focus-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [Pricing & Reimbursement/Market Access Working Group Meeting](https://www.eucope.org/events/pricing-reimbursement-market-access-working-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [EUCOPE Members Meeting](https://www.eucope.org/events/eucope-members-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Saskia Jansen. - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting-2/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Stefano Romanelli. - [Real Word Data/Evidence Working Group Meeting](https://www.eucope.org/events/real-word-data-evidence-working-group-meeting/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Leander Vranken. - [EU HTA Regulation Task Force Meeting](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting-4/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [2024 Digital Health App’ero + Brussels Life Sciences College](https://www.eucope.org/events/2024-digital-health-appero-brussels-life-sciences-college/) - The third Digital Health App'ero (DH App'ero) will take place on the 7th of February between 6 and 7.30 PM, while on the 8th of February, the annual Life Sciences College (LSC) day will address cutting-edge trends and hot topics from 8.30 AM to 5 PM. This year’s keynote address will be presented by Scott Gottlieb, Former - [EUCOPE’s Life Science Lectures – Episode Four](https://www.eucope.org/events/eucopes-life-science-lectures-episode-four-2/) - LIFE SCIENCE LECTURES – Webinar Series Episode 4 – 14 December 2023 (15:00 – 15:40 CET) Leveraging early advice opportunities in EU HTA On the fourth episode, we discuss how best to navigate early advice opportunities with the new EU health technology assessment (HTA), which will be mandatory for all new oncology products and ATMPs - [Pharmaceutical Strategy Task Force](https://www.eucope.org/events/pharmaceutical-strategy-task-force-2/) - For more information or on how to join, please contact Stefano Romanelli (romanelli@eucope.org). - [Futureproofing EU healthcare systems for timely breakthrough therapies to patients](https://www.eucope.org/events/futureproofing-eu-healthcare-systems-for-timely-breakthrough-therapies-to-patients/) - The event will take place from 14:00 to 15:30 in the European Parliament. The discussion is aimed at explaining the role of regulatory data protection for the development and delivery of breakthrough therapies to EU patients, in the context of the proposed reform to the EU pharmaceutical legislation. It will also aim to examine the - [Good Off Label-Use Practices](https://www.eucope.org/events/good-off-label-use-practices/) - The European Brain Council (EBC), with support from EUCOPE, will organise a breakfast meeting with the topic: ”Good off-label use practices: Where are we? What next?” in the European Parliament from 08:00-09:30 CET. The event is hosted by MEP Stelios Kympouropoulos (EPP, Greece). The goals of this event are to reconnect with the Good off-label use - [R&D Focus Group](https://www.eucope.org/events/rd-focus-group/) - For more information or on how to join, please contact Dr Axel Korth (Korth@eucope.org) - [Pharmaceutical Strategy Task Force](https://www.eucope.org/events/pharmaceutical-strategy-task-force/) - For more information or meeting details, please contact Stefano Romanelli (romanelli@eucope.org) - [World EPA Congress](https://www.eucope.org/events/world-epa-congress/) - The world-leading healthcare evidence, pricing, and access congress is taking place in Amsterdam in 2024. The main topics that will be covered during the event are the following: Market Access, Rare Diseases, Evidence, Pricing, Emerging Markets, HTA/Payers, Advanced Therapies, Health Economics & Outcomes Research, Patient Advocacy and Big Data & Digital Health - [Paediatrics in the review of the Pharmaceutical Package](https://www.eucope.org/events/paediatrics-in-the-review-of-the-pharmaceutical-package/) - The in-person expert briefing session hosted by MEP Radka Maxová (S&D, CZ) in the European Parliament will focus on the complexities surrounding developing and producing paediatric medicines in Europe. Additionally, it will seek to underscore the possibilities for establishing a European framework that facilitates quicker patient access to these medications. - [World Orphan Drug Congress 2023](https://www.eucope.org/events/world-orphan-drug-congress-2023/) - The World Orphan Drug Congress is the largest and most established orphan drugs & rare diseases meeting of its kind across the globe. - [EFGCP Better Medicines for Children Conference 2023](https://www.eucope.org/events/efgcp-better-medicines-for-children-conference-2023/) - #The EFGCP “Better Medicines for Children” Conference is an annual flagship event providing a unique opportunity to share best practice and and discuss paediatric updates. The conference will focus on Multi-stakeholders’ collaboration, its challenges and solutions, and in particular its value, with a focus on what has been achieved in Europe, in the US and - [European Conference on Rare Diseases & Orphan Products (ECRD 2024)](https://www.eucope.org/events/european-conference-on-rare-diseases-orphan-products-ecrd-2024/) - Action Within Reach: Pioneering Solutions for Rare Diseases. The European Conference on Rare Diseases & Orphan Products (ECRD) is the largest, patient-led policy-shaping conference for rare diseases taking place in Europe. ECRD is an instrumental tool to achieve policy objectives for people living with a rare disease. The conference aims to harness the power of - [Paediatric Focus Group Meeting](https://www.eucope.org/events/paediatric-focus-group-meeting/) - This is for EUCOPE Members only. For information regarding the agenda or dial-in details, please contact Stefania Alessi (alessi@eucope.org) - [Cell & Gene Therapy Manufacturing & Commercialization Europe](https://www.eucope.org/events/cell-gene-therapy-manufacturing-commercialization-europe-2/) - Join us in Dublin for the premier Cell & Gene Therapy Manufacturing & Commercialization Europe event on 4-7 December 2023. This groundbreaking congress is your gateway to revolutionary manufacturing, commercialization, and analytical strategies in the field! World-renowned leaders will share the latest process development, analytical and market access strategies to improve manufacturing scalability, quality and - [EUCOPE's Life Science Lectures - Episode Four](https://www.eucope.org/events/eucopes-life-science-lectures-episode-four/) - On the fourth episode, we will talk about regulatory pathways, and how the revised framework can improve regulatory processes in the EU. - [EU Pharma Strategy Task Force Meeting (Oct 2023)](https://www.eucope.org/events/eu-pharma-strategy-task-force-meeting-oct-2023/) - for more information, please contact Stefano Romanelli (romanelli@eucope.org) - [EU HTA Regulation Task Force Meeting (Oct 2023)](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting-oct-2023/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [DIA HTA Forum 2023](https://www.eucope.org/events/dia-hta-forum-2023/) - The DIA HTA Forum will bring together key stakeholders, including representatives from the European Commission, EMA, HTA Coordination Group, Patients, Clinicians, and Industry representatives. This is your opportunity to engage directly with key experts, ask pressing questions, and gain insights to prepare for the implementation of the HTA regulation. With a strong commitment to open - [ACCESS 2023 Europe Annual Meeting and Expo](https://www.eucope.org/events/access-2023-europe-annual-meeting-and-expo/) - Join leading market access, reimbursement and pricing professionals at the ACCESS Europe 2023 Annual Meeting & Expo, organized by the International Market Access Society (IMAS), as we bring together leaders and innovators from across industry, academia and agencies to share best practices and shape the patient access framework to therapies across the region and globally. - [EMA Clinical Trial Information System (CTIS) Information Day](https://www.eucope.org/events/ema-clinical-trial-information-system-ctis-information-day/) - The virtual event aims to support sponsors of clinical trials in preparing and proceeding with the transition of their clinical trials to meet the deadline of 30 January 2025. Commercial and non-commercial sponsors with experience in transitioning trials as well as representatives from EMA and EU/EEA member states will share insights and best practices. - [EUCOPE's Life Science Lectures - Episode Three](https://www.eucope.org/events/eucopes-life-science-lectures-episode-three/) - On the third episode, we will talk about the interactions between the EU Health Technology Assessment (HTA) Regulation and the Pharmaceutical Package. - [EU Pharma Strategy Task Force Meeting (Sept 2023)](https://www.eucope.org/events/eu-pharma-strategy-task-force-meeting-sept-2023/) - for more information, please contact Stefano Romanelli (romanelli@eucope.org) - [HERA Steering Group Meeting (Aug 2023)](https://www.eucope.org/events/hera-steering-group-meeting-aug-2023/) - For more information, please contact Leander Vranken vranken@eucope.org - [OMP Working Group Meeting (Nov 2023)](https://www.eucope.org/events/omp-working-group-meeting-nov-2023/) - For more information or meeting details, please contact Victor Maertens (Maertens@eucope.org) - [European Health Forum Gastein: "European rare disease research in crisis?"](https://www.eucope.org/events/european-health-forum-gastein-european-rare-disease-research-in-crisis/) - European Rare Disease Research in crisis? An all-hands approach to secure innovation This session aims to break down the barriers, challenge prejudices, and spark a dynamic conversation among stakeholders involved in Research and Development (R&D) for therapies of rare diseases across Europe. We will explore how patient and health system interests intersect with the perspectives - [World Cancer Series Europe 2023](https://www.eucope.org/events/world-cancer-series-europe-2023/) - A bold ambition for excellent cancer control for all citizens in Europe Economist Impact’s 9th Annual World Cancer Series: Europe is taking place in Brussels this September. The two-day summit features over 90 speakers and welcomes an audience representing policymakers, healthcare providers, industry leaders, academics, patient groups and investors. The 2023 agenda will build on last year’s - [“Time to improve the life of people living with ALS | Policy recommendations for improved diagnosis, care, and treatment”](https://www.eucope.org/events/time-to-improve-the-life-of-people-living-with-als-policy-recommendations-for-improved-diagnosis-care-and-treatment/) - Amyotrophic lateral sclerosis (ALS) is a rare neurodegenerative disease, affecting 32.000 adults in Europe (i.e., the European Union countries, plus the United Kingdom). ALS progresses rapidly, relentlessly, and irreversibly, giving people living with ALS a life expectancy of 2-5 years after the onset of the symptoms. The EU ALS Coalition was launched in March 2023 - [ACCESS Europe 2023 Annual Meeting & Expo](https://www.eucope.org/events/access-europe-2023-annual-meeting-expo/) - Join leading market access, reimbursement and pricing professionals at the ACCESS Europe 2023 Annual Meeting & Expo, organized by the International Market Access Society (IMAS), as they bring together leaders and innovators from across industry, academia and agencies to share best practices and shape the patient access framework to therapies across the region and - [Advanced Therapies Congress 2024](https://www.eucope.org/events/advanced-therapies-congress-2024/) - The Advanced Therapies Congress features speakers from across the entire value chain of cell and gene therapy development - [EU HTA Regulation Task Force (Sept 2023)](https://www.eucope.org/events/eu-hta-regulation-task-force-sept-2023/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Cell & Gene Therapy Working Group (Nov 2023)](https://www.eucope.org/events/cell-gene-therapy-working-group-nov-2023/) - For more information on how to join, please contact Victor Maertens (maertens@eucope.org) - [P&R/Market Access Working Group Meeting (Sept 2023)](https://www.eucope.org/events/pr-market-access-working-group-meeting-sept-2023/) - For more information, please contact Matias Olsen (olsen@eucope.org) - [Regulatory Working Group Meeting (July 2023)](https://www.eucope.org/events/regulatory-working-group-meeting-july-2023/) - For more information on how to join, please contact Axel Korth (korth@eucope.org) - [EU Pharmaceutical Strategy Task Force Meeting (July 2023)](https://www.eucope.org/events/eu-pharmaceutical-strategy-task-force-meeting-july-2023/) - for more information, please contact Stefano Romanelli (romanelli@eucope.org) - [TEC Space Series: How to do life-science in space, and why?](https://www.eucope.org/events/tec-space-series-how-to-do-life-science-in-space-and-why/) - The Exploration Company is excited to announce the first event of our "TEC Space Series" which will focus on Life-science in space. The event will take place on July 6th and we have an impressive lineup of speakers ready to share their insights and experiences about Life-science in space. Thursday, 06.07.2023, 16.00-17.00 CEST (Zoom) Participation - [Genomics Working Group Meeting (July 2023)](https://www.eucope.org/events/genomics-working-group-meeting-july-2023/) - For the agenda or meeting details, please contact Matias Olsen (olsen@eucope.org) - [EU HTA Regulation Task Force Meeting (July)](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting-july/) - This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen. - [Unmet medical needs in rare disease: A case study from Amyloidosis](https://www.eucope.org/events/unmet-medical-needs-in-rare-disease-a-case-study-from-amyloidosis/) - This panel conversation aims to raise awareness on rare diseases and on their impact on patients and European health systems. It is a critical juncture for rare disease policy. Indeed, the EU pharmaceutical legislation on rare diseases1 is to be revised and the Spanish Presidency is to set rare diseases as a priority. This political - [BIO International Convention #BIO2023](https://www.eucope.org/events/eucope-hosted-sessions-at-bio2023/) - We are excited to invite you to join EUCOPE during its two-panel sessions during the largest global event for the biotech & life sciences industry. - [An EU Ecosystem for Rare Diseases: The OD Expert Group Proposals for Navigating the Challenges Ahead](https://www.eucope.org/events/an-eu-ecosystem-for-rare-diseases-the-od-expert-group-proposals-for-navigating-the-challenges-ahead/) - This event brings together a diverse group of rare disease experts to discuss policy recommendations for improving the EU legislative framework for orphan drugs - [Enhancing the EU’s role in rare disease management: the case of Myasthenia Gravis](https://www.eucope.org/events/enhancing-the-eus-role-in-rare-disease-management-the-case-of-myasthenia-gravis/) - The first-ever European MG Awareness Day, supported by argenx, aims to raise awareness about MG and its consequences for patients and their caregivers. - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting-5/) - For more information or on how to join, please contact Stefano Romanelli. - [EUCOPE's Life Science Lectures - Webinar Episode One](https://www.eucope.org/events/eucopes-life-science-lectures-webinar-episode-one/) - A multi-stakeholder webinar series focusing on aspects of the EU Pharma Package that are crucial to sustaining a competitive pharmaceutical ecosystem in Europe. - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting-4/) - For more information or on how to join, please contact Stefano Romanelli. - [The 17th Clinical Trials Nexus Conference](https://www.eucope.org/events/the-17th-clinical-trials-nexus-conference/) - The 17th Clinical Trials Nexus Conference is set to take place in Amsterdam on the 15th and 16th of June, 2023. This conference brings together professionals and experts in the field of clinical trials to discuss the latest trends, technologies, and best practices in clinical operations, clinical outsourcing, medical affairs, and patient-centricity. With a focus - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting-2/) - For meeting details or agenda, please contact Victor Maertens. - [Evoke Incisive Health's #BreakTheBubble #2](https://www.eucope.org/events/evoke-incisive-healths-breakthebubble-2/) - Evoke Incisive Health is organising the upcoming breakfast debate 'Getting Ahead of Medicine Shortages: The Way Forward in Europe', on April 26 - [Pharmageddon: Rocket Fuel for Life Science Disruptors](https://www.eucope.org/events/pharmageddon-event/) - Pharmageddon is a brand new, two-day experience where attendees will work in small teams, to tackle our biggest challenges in healthcare. - [Nordic Rare Disease Summit 2023](https://www.eucope.org/events/nordic-rare-disease-summit-2023/) - The Nordic Rare Disease Summit will bring together experts and decision makers, building on the success of the first Nordic Rare Disease Summit in 2021 - [Seminar: The BSG's verdict on Rapiscan® - What pharmaceutical manufacturers need to know](https://www.eucope.org/events/seminar-the-bsgs-verdict-on-rapiscan-what-pharmaceutical-manufacturers-need-to-know/) - The seminar aims to understand the impact of the judgment of the Federal Social Court on Rapiscan on the pricing and benefit assessment of soloists in the pharmaceutical industry. Participants should develop an understanding of the legal aspects of the judgment as well as the impact on products, price negotiations and compensation for invalid discounts. The - [Avanzanite Bioscience's "Knights for Rare"](https://www.eucope.org/events/avanzanite-biosciences-knights-for-rare/) - Avanzanite Bioscience would like to invite fellow EUCOPE members to the first annual Knights for Rare, a fundraiser and walking dinner on Tuesday, 21 March 2023 from 1900–2130 at the Royal Industrieele Groote Club, in Dam Square, Amsterdam. This year the event will benefit the Acanthamoeba Keratitis Eye Foundation, a member of Eurodis and the first foundation in the world dedicated to this - [DIA Europe 2023](https://www.eucope.org/events/dia-europe-2023/) - For it's 35th anniversary, DIA Europe is back in Basel, where all thought leaders meet in person to discuss, inspire, and network. - [OD Expert Group – Workshop in the European Parliament](https://www.eucope.org/events/od-expert-group-workshop-in-the-european-parliament/) - After more than two years of work and close cooperation, we are honoured to announce the launch of the OD Expert Group policy proposals at a workshop in the European Parliament. The event will be hosted by MEP Pernille Weiss on March 22, 13.00-14.30 at the European Parliament and it will represent an occasion to build up a fruitful discussions on the - [Regulatory Working Group - Q3 Meeting](https://www.eucope.org/events/regulatory-working-group-q3-meeting/) - For more information or on how to join, please contact Dr Axel Korth - [Pharma Partnering Summit](https://www.eucope.org/events/pharma-partnering-summit/) - The Pharma Partnering Summit is an exclusive Life Sciences Industry event, with the aim to help companies expand their network and put together licensing deals, research collaborations and financing. Our platform brings together senior executives from different parts of the world specialising in Business Development & Licensing, Alliance Management, Research Collaborations, M&A and Investment. In - [Better Decision-Making for Better Outcomes: Harnessing the Power of RWE](https://www.eucope.org/events/better-decision-making-for-better-outcomes-harnessing-the-power-of-rwe/) - The COVID-19 pandemic has shown us how real-world data (RWD) can be used for medicine authorisation and assessment, providing an invaluable complement to clinical trial data when it is needed most. For rare diseases, RWD can support regulatory decisions when small population numbers make clinical trials infeasible. For influenza and other respiratory diseases, RWD is critical to understanding - [WEBINAR - Drastic changes in Europe’s 1st launch country: How recent legislative changes impact the German P&R landscape](https://www.eucope.org/events/webinar-drastic-changes-in-europes-1st-launch-country-how-recent-legislative-changes-impact-the-german-pr-landscape/) - EUCOPE's Alexander Natz and Thomas Ecker from Ecker + Ecker will discuss the implications and relevance of the recent legislative changes for a global audience. - [P&R/Market Access Working Group Meeting](https://www.eucope.org/events/pr-market-access-working-group-meeting-4/) - For more information or how to join, please contact Matias Olsen. - [World Rare Disease Day 2023](https://www.eucope.org/events/rare-disease-day-2023/) - Rare Disease Day is the globally-coordinated movement on rare diseases, working towards equity and access to diagnosis for people living with a rare disease. - [Evoke Incisive Health's ''Break the Bubble''](https://www.eucope.org/events/evoke-incisive-healths-break-the-bubble/) - How can we rethink stakeholder engagement by unleashing the potential of EU funds? Join the #BreakTheBubble event series launch by Evoke Incisive Health - [Advanced Therapies Congress 2023](https://www.eucope.org/events/advanced-therapies-congress-2023/) - The event in 2023 will bring together 2,000 attendees from across the ATMP industry from pharma, biotech, research, regulatory bodies, HTAs investment and start-ups; will feature an agenda with 8 focused topic tracks and 300 speakers; showcase an action-packed exhibition with 100 sponsors and exhibitors demonstrating their latest solutions, tech and products; gather 200 start-up - [World Orphan Drug Congress USA](https://www.eucope.org/events/world-orphan-drug-congress-usa/) - The World Orphan Drug Congress brings together leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers. The conference is a place to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapies. Join for three days in Washington for the most comprehensive - [EUCOPE Town Hall Meeting](https://www.eucope.org/events/eucope-town-hall-meeting/) - A EUCOPE Members Only event. For further information, or if you haven't received the dial-in details, please contact Stefano Romanelli. - [Digital Health Working Group Meeting](https://www.eucope.org/events/digital-health-working-group-meeting-2/) - For more information or to join, please contact Leander Vranken - [OMP Working Group Meeting](https://www.eucope.org/events/omp-working-group-meeting/) - For more information or on how to join, please contact Victor Maertens - [Addressing the unmet medical needs of people living with a rare disease: What will it take?](https://www.eucope.org/events/addressing-the-unmet-medical-needs-of-people-living-with-a-rare-disease-what-will-it-take/) - The rare disease community will discuss how the EU can continue to play a central role in the rare disease space by stimulating research and innovation. - [World Evidence, Pricing and Access (EPA) Congress](https://www.eucope.org/events/world-evidence-pricing-and-access-epa-congress/) - **EUCOPE is a supporting partner of the EPA Congress Venue: RAI Congress Centre, Amsterdam The EPA Evidence, Pricing and Access World Congress is Europe’s largest congress in market access, pricing and evidence featuring 300 speakers, more than 100 sponsors & exhibitors, 6 tracks, and over 1200 attendees from pharma, biotech and Payers/HTA’s. Including Evidence, Market - [Europe Rare Disease Summit 2023](https://www.eucope.org/events/europe-rare-disease-summit-2023/) - With a new Rare Disease Day coming up, Bamberg Health in collaboration with key actores of the industry, is organizing the Europe Rare Disease Summit in Madrid. - [The Economist's Cell & Gene Therapy Summit 2023](https://www.eucope.org/events/the-economists-cell-gene-therapy-summit-2023/) - Examine how healthcare systems, pricing and policies need to evolve before essential cell and gene therapies can become mainstream. - [Genomics Working Group Meeting](https://www.eucope.org/events/genomics-working-group-meeting-3/) - For more information or to join, please contact Matias Olsen. - [ACCELERATE 2023 Paediatric Oncology Annual Conference](https://www.eucope.org/events/accelerate-2023-paediatric-oncology-annual-conference/) - **This is not a EUCOPE-related event Join the ACCELERATE Network to discuss, network, share knowledge and engage with our international, multi-stakeholder community on the latest in paediatric oncology drug development. With your contribution, they will continue our mission to accelerate the implementation of new oncology drug development for children and adolescents in a changing global landscape. You - [EU HTA Regulation Task Force Meeting](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting-3/) - For more information or to join, please contact Matias Olsen. - [Cell & Gene Therapy Working Group - Q1 Meeting](https://www.eucope.org/events/cell-gene-therapy-working-group-q1-meeting/) - For more information or on how to join, please contact Victor Maertens - [Cell & Gene Therapy Working Group - Q3 Meeting](https://www.eucope.org/events/cell-gene-therapy-working-group-q3-meeting/) - For more information or on how to join, please contact Victor Maertens - [Regulatory Working Group - Q4 Meeting](https://www.eucope.org/events/regulatory-working-group-q4-meeting/) - For more information or on how to join, please contact Dr Axel Korth - [Regulatory Working Group - Q2 Meeting](https://www.eucope.org/events/regulatory-working-group-q2-meeting/) - For more information or on how to join, please contact Dr Axel Korth - [Regulatory Working Group - Q1 Meeting](https://www.eucope.org/events/regulatory-working-group-q1-meeting/) - For more information or on how to join, please contact Dr Axel Korth - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting-6/) - For more information or on how to join, please contact Stefano Romanelli. - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting-3/) - For more information or on how to join, please contact Stefano Romanelli. - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting-2/) - For more information or on how to join, please contact Stefano Romanelli. - [EU Pharma Strategy Task Force Monthly Meeting](https://www.eucope.org/events/eu-pharma-strategy-task-force-monthly-meeting/) - For more information or on how to join, please contact Stefano Romanelli. - [Life Sciences College: Inside the Mind of Regulators](https://www.eucope.org/events/life-sciences-college-inside-the-mind-of-regulators/) - **This is a EUCOPE-sponsored event Thursday, February 9, 2023 8:30 a.m. – 5:00 p.m. Followed by networking drinks NEW VENUE: Marriott Renaissance, Rue du Parnasse 19, 1050 Bruxelles Join us for our annual life sciences legal conference, bringing together senior members of the European Commission and industry thought leaders. This edition will provide the opportunity to discuss a variety of - [Life Sciences College: Digital Health App'ero](https://www.eucope.org/events/life-sciences-college-digital-health-appero/) - *This is a EUCOPE-sponsored event. Wednesday, February 8, 2023 6:00 p.m. – 7:30 p.m. Followed by networking drinks NEW VENUE: Comet, Place Stephanie 20, 1000 Brussels On the eve of Life Sciences College 2023, we welcome you to our second Digital Health App'ero, featuring a panel discussion with key industry representatives on the use of digital health tools by pharma and - [3rd International Conference on Rare Diseases: Greek Chapter](https://www.eucope.org/events/3rd-international-conference-on-rare-diseases-greek-chapter/) - The 3rd International Conference on Rare Diseases organized by Rare Diseases Greece (RDG), “95” Rare Alliance Greece and Boussias, following the World Rare Disease Day 2023, will take place on February 28 & March 1, 2023. Following the success of the previous two years and having advanced the policy agenda on both national and international - [EIC – EMA Info Day: Regulatory support for the development of innovative medicines and technologies](https://www.eucope.org/events/eic-ema-info-day-regulatory-support-for-the-development-of-innovative-medicines-and-technologies/) - The European Innovation Council (EIC) and the European Medicine Agency (EMA) invite you to attend the EIC-EMA Info Day on January 31, 2023 to hear about the wide range of support services provided by EMA to researchers and SMEs active in research and innovation in the pharmaceutical and med-tech sectors. During the online Info Day, you will learn on - [Incentives Steering Group (ISG) Monthly Catch-up](https://www.eucope.org/events/incentives-steering-group-isg-monthly-catch-up/) - This meeting is closed for the private members of the Incentives Steering Group. - [EU HTA Regulation Task Force](https://www.eucope.org/events/eu-hta-regulation-task-force/) - For more information, please contact Matias Olsen. - [P&R/Market Access Working Group Meeting](https://www.eucope.org/events/pr-market-access-working-group-meeting/) - For more information, please contact Matias Olsen. - [Cure Signature Series: Song of the Cell](https://www.eucope.org/events/cure-signature-series-song-of-the-cell/) - **This is an event from a EUCOPE Member Join us at Cure® for the first installment of our Signature Initiative, where we will be joined by Pulitzer Prize-winning and #1 New York Times bestselling author, Siddhartha Mukherjee to discuss his newest book release, The Song of the Cell: An Exploration of Medicine and the New - [Ecosystème des Tests de Diagnostics Génomiques en France : présentation de la perspective française](https://www.eucope.org/events/ecosysteme-des-tests-de-diagnostics-genomiques-en-france-presentation-de-la-perspective-francaise/) - **This event takes place entirely in French and is co-organised by EUCOPE and Alira Health. Le 7 décembre, nous rencontrerons les principaux experts français afin de mettre en avant les avantages des solutions de diagnostic avancé et aborder les principaux challenges qu’ils rencontrent pour accéder au marché en France. Seront abordés au cours de cet - [European Health Summit](https://www.eucope.org/events/european-health-summit/) - The theme of this year's European Health Summit is "Maintaining Europe's Momentum: Driving Resilience Forward." The European Health Summit 2022 is an exclusive invitation-only event. Due to security reasons, on-the-spot registration will not be possible. Only registered participants will be able to enter the conference space. It is possible to attend European Health Summit virtually. EUCOPE's - [Myasthenia Gravis in Europe: An EU Perspective](https://www.eucope.org/events/myasthenia-gravis-in-europe-an-eu-perspective/) - **This is a EUCOPE Member's Event Myasthenia gravis (MG) is a serious, rare, and chronic neuromuscular autoimmune disease that can cause debilitating and potentially life-threatening muscle weakness. It affects 56,000 to 123,000 people in Europe. On November 29, patients, HCPs and policymakers will discuss the burden of disease in different EU countries and how harmonised - [Biotech Innovation Spotlight: Liquid Biopsy](https://www.eucope.org/events/biotech-innovation-spotlight-liquid-biopsy/) - The event provides an overview of the progressive development and dissemination of liquid biopsy in the German research and care landscape. The programme includes keynote speeches, panel discussions, company presentations, individual workshops and general networking. Some parts of the programme will be held in German, for these sessions we offer simultaneous English translation. Participation in - [Economic Modelling in Cell & Gene Therapy – when to start and when is it too late?’.](https://www.eucope.org/events/economic-modelling-in-cell-gene-therapy-when-to-start-and-when-is-it-too-late/) - This event is run by MAP Patient Access. All EUCOPE members are welcome and places are free. If you can’t attend live, do still register as you will be sent the recording. Join Maciej Maruszczak, Associate Director, Head of HTAM, Head of AI & ML at MAP as he discusses best practice around economic modelling in cell - [DIA - Innovative Therapies in Europe Workshop](https://www.eucope.org/events/dia-innovative-therapies-in-europe-workshop/) - 5 Years of ATMPs on the Market - Lessons Learned On the 30th of November, EUCOPE and DIA invite you to the Innovative Therapies Workshop that will allow you to explore how could we improve access to innovative treatments by accelerating their way to the market, and ultimately to patients. Benefit from early bird rates and - [OMP Working Group Meeting (online)](https://www.eucope.org/events/omp-working-group-meeting-online/) - For more information or to join, please contact Vittoria Carraro. - [Data, Drugs and Devices: Decoding Digital Health](https://www.eucope.org/events/data-drugs-and-devices-decoding-digital-health/) - **THIS IS A EUCOPE MEMBER'S EVENT Digital Health is now a major focus not only for the life sciences and healthcare industry, but also for technology, telecoms, and retail companies, who are expanding their services and products into this space. From medical apps, digital therapeutics and AI diagnostic tools to blood glucose monitors, medical software - [Driving change in rare disease policy: Addressing health inequalities for people living with sickle cell disease](https://www.eucope.org/events/driving-change-in-rare-disease-policy-addressing-health-inequalities-for-people-living-with-sickle-cell-disease/) - **THIS IS NOT A EUCOPE-RELATED EVENT 25 October 2022 from 5.30 pm to 7 pm CET (European Parliament, Brussels, Belgium) During the discussion, panellists will reflect upon health inequalities and challenges faced by sickle cell disease patients and that disproportionately impact patients in Europe. In the context of the European Year of Youth 2022, this event - [Competitiveness of herbal medicines in Europe](https://www.eucope.org/events/competitiveness-of-herbal-medicines-in-europe/) - In recent years, manufacturers of food, and in particular of food supplements belonging to this category, have been launching more and more products on the market that also contain herbal substances (so-called botanicals). These are often extracts that consumers are also familiar with from herbal medicines. It is not uncommon for health claims to be - [EUCOPE Members' Meeting II](https://www.eucope.org/events/eucope-members-meeting-ii/) - For more information or how to join, please contact Saskia Jansen. - [EUCOPE Members' Meeting III](https://www.eucope.org/events/eucope-members-meeting-iii/) - For more information or how to join, please contact Saskia Jansen. - [EUCOPE Members' Meeting I](https://www.eucope.org/events/eucope-members-meeting-i/) - For more information or how to join, please contact Saskia Jansen. - [Digital Health Working Group Meeting](https://www.eucope.org/events/digital-health-wg-meeting/) - For more information or to join, please contact Leander Vranken (vranken@eucope.org) - [2nd Rare CNS & Neurodevelopmental Drug Development Summit](https://www.eucope.org/events/rarecns-summit/) - With more clinical data emerging, neurodevelopmental drug development is advancing from hypotheticals to real-life clinical results, outcomes, and functional biomarkers, catapulting this critical field forwards. Join 100+ peers this November at the 2nd Rare CNS & Neurodevelopmental Drug Development Summit - the only industrydedicated drug development forum for large pharma, biotech, academia, and patient advocacy - [Cell & Gene Therapy Manufacturing & Commercialization Europe](https://www.eucope.org/events/cell-gene-therapy-manufacturing-commercialization-europe/) - Europe’s cell and gene therapy congress for groundbreaking manufacturing, commercialization & supply chain strategies. - [World Orphan Drug Congress - EU](https://www.eucope.org/events/world-orphan-drug-congress-eu/) - The World Orphan Drug Congress is an award-winning event with an exhibition that has grown to become the largest and most established orphan drugs & rare diseases meeting of its kind across the globe. Now in its 13th annual edition, the World Orphan Drug Congress Europe, together with the co-located Cell & Gene Therapy Congress, - [EU HTA Regulation Task Force Meeting](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting-2/) - For more information, please contact Task Force leader Matias Olsen. - [RareConversations Conference](https://www.eucope.org/events/rareconversations-conference/) - Alexion is happy to invite you to their annual Rare Conversations conference, “Rare Disease Policies: Pioneering the way towards a resilient ecosystem”. The event will reflect on several aspects that may be included in the new legislative framework, trying to answer the question: How to create a resilient rare disease ecosystem for the next decade? During - [TRANSFORM “Launch of Charter for EU Cooperation to Enable Safe and Timely Patient Access to Advanced Therapies in Europe"](https://www.eucope.org/events/transform-launch-of-charter-for-eu-cooperation-to-enable-safe-and-timely-patient-access-to-advanced-therapies-in-europe/) - TRANSFORM’s first in-person Conference to be held under the auspices of the Czech EU Presidency, at the European Parliament, Brussels, Altiero Spinelli Room 1E2 - [Compounding as a specialism: a European perspective](https://www.eucope.org/events/compounding-as-a-specialism-a-european-perspective/) - EUCOPE will be participating as a speaker at an event titled “Compounding as a specialism: a European perspective”, that is being organised by the Dutch association of specialised compounding pharmacies (NGB). The symposium is taking place over the course of a day on 22 September, between 9 am – 6 pm (CET), in Veenendaal, Netherlands - [RWE4Decisions "Supporting HTA/Payer decision-making: Spotlight on health data initiatives in Germany"](https://www.eucope.org/events/rwe4decisions-supporting-hta-payer-decision-making-spotlight-on-health-data-initiatives-in-germany/) - On 21 September 2022, join the RWE4Decisions multi-stakeholder community from 15.00 to 16.30 CET to hear updates on health data initiatives in Germany that could support the development of real-world evidence to enable HTA/Payer decision-making. This is the second public webinar to update on how countries are developing their data environments in a way that - [8th annual World Cancer Series: Europe 2022](https://www.eucope.org/events/8th-annual-world-cancer-series-europe-2022-2/) - The Economist’s 8th Annual World Cancer Series: Europe convenes a wide range of stakeholders critical to effective cancer care, to drive innovation, equity and excellence in cancer control across Europe. - [P&R/Market Access Working Group Meeting](https://www.eucope.org/events/pr-market-access-working-group-meeting-3/) - For more information, please contact Matias Olsen. - [The Future of Rare Diseases in Europe (German Event)](https://www.eucope.org/events/the-future-of-rare-diseases-in-europe-german-event/) - ‘The future of rare diseases in Europe - the revision of the European Orphan Regulation and its implications in Germany’ will take place entirely in German. - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting/) - [P&R/Market Access Working Group Meeting](https://www.eucope.org/events/pr-market-access-working-group-meeting-2/) - for more information, please contact Maren von Fritschen. - [EU HTA Regulation Task Force Meeting](https://www.eucope.org/events/eu-hta-regulation-task-force-meeting/) - For more information, please contact Matias Olsen. - [Cell & Gene Working Group Meeting](https://www.eucope.org/events/cell-gene-working-group-meeting/) - For more information, please contact Victor Maertens. - [Genomics Working Group Meeting](https://www.eucope.org/events/genomics-working-group-meeting-2/) - For more information, please contact Matias Olsen. - [Pharmaceutical Strategy Task Force Meeting](https://www.eucope.org/events/pharmaceutical-strategy-task-force-meeting/) - For more information, please contact Victor Maertens. - [EUCOPE & BPI's End of Summer Mixer](https://www.eucope.org/events/eucope-bpis-end-of-summer-mixer/) - Join the EUCOPE and BPI for an intimate and informal affair to discuss the future of innovation for life sciences in Europe. - [Genomics Working Group Meeting](https://www.eucope.org/events/genomics-working-group-meeting/) - Contact Matias Olsen for more information - [Regulatory Working Group Meeting](https://www.eucope.org/events/regulatory-working-group-meeting-2/) - Contact Maren von Fritschen for more information. - [EUCOPE Members Quarterly Meeting](https://www.eucope.org/events/eucope-members-quarterly-meeting/) - Contact Saskia Jansen for more information. - [German Pharma Love Update - Munich](https://www.eucope.org/events/german-pharma-love-update-munich/) - **Please note that this is an event in German language. Hogan-Lovell looks forward to welcoming you at the venue starting 4.30 pm. From 5.00 pm to 6.45 pm you can expect presentations around the current trends in pharma law, according to the motto: a pharma-law update in the truest sense! First, we want to give - [German Pharma Law Update - Frankfurt](https://www.eucope.org/events/german-pharma-law-update-frankfurt/) - **Please note that this is an event in German language. Hogan-Lovell looks forward to welcoming you at the venue starting 4.30 pm. From 5.00 pm to 6.45 pm you can expect presentations around the current trends in pharma law, according to the motto: a pharma-law update in the truest sense! First, we want to give - [German Pharma Law Update - Hamburg](https://www.eucope.org/events/german-pharma-law-update-hamburg/) - **Please note that this is an event in German language. Hogan-Lovell looks forward to welcoming you at the venue starting 4.30 pm. From 5.00 pm to 6.45 pm you can expect presentations around the current trends in pharma law, according to the motto: a pharma-law update in the truest sense! First, we want to give - [Webinar: HealthTech Innovation Days](https://www.eucope.org/events/webinar-healthtech-innovation-days/) - You are invited to a webinar focused on an event organized by HealthTech For Care: HealthTech Innovation Days. During this webinar you will grab all information you need to apply More information about the webinar: ❓When: June 30 from 5:00 pm to 6:00pm CET ❓How to join: Conference via Teams. Invitation ? here Programme: - [The Future of Rare Diseases in Europe and Czech Republic: What are the Solutions at EU and National Level?](https://www.eucope.org/events/the-future-of-rare-diseases-in-europe-and-czech-republic-what-are-the-solution-at-eu-and-national-level/) - JOIN US And get an insight into the ways the European framework on rare diseases paves the way forward and complements actions at national level. - [MedTech Evidence & Value Conference](https://www.eucope.org/events/medtech-evidence-value-conference-developing-compelling-clinical-economic-evidence-to-demonstrate-medical-device-value/) - This conference will help you: 1. Understand how to most efficiently develop global evidence that can best provide value to key local markets 2. Benchmark what are today’s and tomorrow’s ideal market access & cross-functional capabilities to maximise effectiveness in larger or smaller companies 3. Appreciate how to best leverage evidence to demonstrate value to key payers and HTAs EUCOPE's Alexander Natz - [Staying Ahead of the Curve - Issues on the Radar for Pharma and Medical Devices Companies](https://www.eucope.org/events/staying-ahead-of-the-curve-issues-on-the-radar-for-pharma-and-medical-devices-companies/) - 8:30 a.m. – 5:10 p.m. followed by networking drinks Breakfast will be served from 8:30 a.m. THE HOTEL – Bd. de Waterloo 38, 1000 Bruxelles Please join us for our annual life sciences legal conference, bringing together senior members of the European Commission and industry thought leaders. This edition will focus on a variety of topics, including the latest - [Digital Health App'ero](https://www.eucope.org/events/digital-health-appero/) - On the eve of the Life Sciences College 2022, Sidley welcomes you to our first Digital Health App'ero, which will feature a panel discussion with key industry representatives on the use of digital health tools by pharma and medtech companies. The panel will be followed by a networking forum for professionals in this space. - [Cell & Gene Therapy Working Group Meeting](https://www.eucope.org/events/cell-gene-therapy-working-group-meeting-2/) - [11th European Conference on Rare Diseases & Orphan Products (ECRD 2022)](https://www.eucope.org/events/11th-european-conference-on-rare-diseases-orphan-products-ecrd-2022/) - The European Conference on Rare Diseases & Orphan Products (ECRD) is recognised globally as the largest, patient-led rare disease event. - [Bulgarian Association for Drug Information (BADI) - Annual Conference](https://www.eucope.org/events/bulgarian-association-for-drug-information-badi-annual-conference/) - The Bulgarian Association for Drug Information (BADI) will host its annual conference on "Revolution in Regulatory Affairs" - [3rd Gene Therapy for Neurological Disorders Europe](https://www.eucope.org/events/3rd-gene-therapy-for-neurological-disorders-europe/) - EUCOPE will be leading the pre-conference Workshop D: Overcoming Gene Therapy Pricing & Reimbursement Challenges in Europe on 11 July at 1:30 - [Nordic Growth Summit](https://www.eucope.org/events/nordic-growth-summit/) - The Nordic Growth Summit is a gathering of biopharma, medtech and healthtech organizations leading Scandinavian life sciences and collectively lifting the global life sciences. - [‘Piloting the EU HTA before 2025 – Opportunities for companies to engage’](https://www.eucope.org/events/piloting-the-eu-hta-before-2025-opportunities-for-companies-to-engage/) - Join Flora Giorgio, Deputy Head of Unit, B6 Medical Devices and HTA, DG SANTE, European Commission, Adam Parnaby, Vice-Chair EFPIA HTA WG & Senior Director, Market Access Policy, BMS, Alexander Natz, Secretary-General, EUCOPE and Christian Hill, Founder and Chief Strategy Officer, MAP Patient Access as they discuss piloting the EU HTA before 2025 and the opportunities for companies to engage. Attend - [Advanced Therapies Congress LIVE!](https://www.eucope.org/events/advanced-therapies-congress-live/) - During the last 2 years the Advanced Therapies Industry has seen great leaps forward in innovation, creative solutions to challenging setbacks, new technologies, interest, and investment. The last two years have also taught us we can get by with meeting virtually, but what we really need to thrive and do business is face to face - [MassBio: State of Possible 2022](https://www.eucope.org/events/massbio-state-of-possible-2022/) - MassBio’s 2022 #StateofPossible conference on May 5 at the Royal Sonesta Hotel celebrates how the life sciences make the impossible possible. - [“Fit for future: A long term Industrial strategy for a competitive Europe”](https://www.eucope.org/events/fit-for-future-a-long-term-industrial-strategy-for-a-competitive-europe/) - Sponsored by EUCOPE, the Official Spanish Chamber of Commerce in Belgium and Luxembourg has the pleasure to invite you next Thursday, April 28th at 12.30pm to the in-person luncheon debate in Brussels with Kerstin Jorna, Director-Generalfor Internal Market, Industry, Entrepreneurship and SMEs. She will discuss European innovation across several sectors in Europe, including pharmaceuticals and - [World Orphan Drug Congress USA 2022](https://www.eucope.org/events/world-orphan-drug-congress-usa-2022/) - EUCOPE's Alexander Natz and Vittoria Carraro will speak at the 12 July session "Innovative payment models for Cell and Gene therapies in Europe." - [P&R/Market Access Working Group](https://www.eucope.org/events/pr-market-access-working-group/) - Meeting for the Pricing & Reimbursement/Market Access Working Group - [The new EU-wide health technology assessment for innovative drugs](https://www.eucope.org/events/the-new-eu-wide-health-technology-assessment-for-innovative-drugs/) - In this workshop, the importance of the new EU-wide Health Technology Assessment scheme for the biotech industry will be presented. - [European HTA: What have we learned, what lies ahead?](https://www.eucope.org/events/european-hta-what-have-we-learned-what-lies-ahead/) - Join AMS Advanced Medical Services and EUCOPE on 4th May for the webinar “European HTA - What have we learned, what lies ahead?” It will be an opportunity to get an insight into our experiences and learnings from EUnetHTA Joint Assessment projects and to discover how you can best prepare for the upcoming mandatory EU - [Incentives Steering Group (ISG) Meeting](https://www.eucope.org/events/incentives-steering-group-isg-meeting/) - Monthly Meeting for the Incentives Steering Group. - [Rare Conversations 2022 - Game changing opportunities for the R&D community to address existing challenges in rare diseases](https://www.eucope.org/events/rare-conversations-2022-game-changing-opportunities-for-the-rd-community-to-address-existing-challenges-in-rare-diseases/) - The event will revolve around discussions on how the revision of the OMP Regulation can create a space for opportunities for scientific progress. - [World Health Day](https://www.eucope.org/events/world-health-day/) - In the midst of a pandemic, a polluted planet, increasing diseases like cancer, asthma, heart disease, on World Health Day 2022, WHO will focus global attention on urgent actions needed to keep humans and the planet healthy and foster a movement to create societies focused on well-being. - [EUCOPE Members' Meeting](https://www.eucope.org/events/eucope-members-meeting/) - [EU Virtual Roundtable: ‘Equality of access to genomic diagnostics for rare disease patients across Europe’](https://www.eucope.org/events/eu-virtual-roundtable-equality-of-access-to-genomic-diagnostics-for-rare-disease-patients-across-europe/) - The event will focus on the role of genomics in enabling equal and timely rare disease diagnosis and consequently timely access to the right treatment. - [Drug Prices Conference 2022](https://www.eucope.org/events/drug-prices-conference-2022/) - This online conference sheds light on the new set of rules in Germany and looks at European issues. Here you can get first-hand information on the current trends in the pricing and reimbursement of medicines. EUCOPE’s Alexander Natz will headline the topic “Medicines Strategy for Europe: What’s Next?” - [DIA Europe Conference](https://www.eucope.org/events/dia-europe-conference/) - DIA Europe 2022 is the largest neutral event in the life science industry in Europe featuring EUCOPE and other key stakeholders from EMA, European Commission, other National Authorities, Industry, Patient Organizations, and Academia to discuss key healthcare issues and to build bridges between key policy decisions and patients’ needs. The exciting programme this year brings - [EU HTA & EUnetHTA21 – The pathway for implementation of the EU HTA system in 2025 – helping companies prepare for submission](https://www.eucope.org/events/eu-hta-eunethta21-the-pathway-for-implementation-of-the-eu-hta-system-in-2025-helping-companies-prepare-for-submission/) - Join EUNetHTA, EUCOPE and MAP Patient Access as they discuss the implementation of the EU HTA system in 2025. This webinar will help attendees to: Understand details about the stepwise entry into force of the EU HTA starting in January 2025 Learn how EUnetHTA21 will develop the methodology and procedural rules until 2025 Understand details - [Q2 Cell & Gene Therapies Working Group Meeting](https://www.eucope.org/events/q2-cell-gene-therapies-working-group-meeting/) - [Q2 Regulatory Working Group Meeting](https://www.eucope.org/events/q2-regulatory-working-group-meeting/) - [Digital Health Working Group Meeting](https://www.eucope.org/events/digital-health-working-group-meeting/) - [Orphan Medicinal Products (OMP) meeting](https://www.eucope.org/events/orphan-medicinal-products-omp-meeting/) ## Member News - [OMP WG | EMA fees | #LifeScienceLectures Recap | Members Meeting next week](https://www.eucope.org/membersonly/omp-wg-ema-fees-lifesciencelectures-recap-members-meeting-next-week/) - In this email, we share a reminder for next week’s hybrid OMP Working Group meeting featuring a DG SANTE representative, a review of the EMA fee restructuring, the event recap of our first Life Science Lectures episode and a final reminder for next week’s Members Meeting to send in your proxy votes. Reminder: Orphan Medicinal - [Scientific Advice Survey | Pharma Package feedback | OMP WG Reminder](https://www.eucope.org/membersonly/scientific-advice-survey-pharma-package-feedback-omp-wg-reminder/) - In this email, we share our new survey on Scientific Advice (SA) procedures, ask for your comments on EUCOPE’s Pharma Package feedback and a reminder about the upcoming OMP Working Group Meeting. Survey on Scientific Advice (SA) Procedures EUCOPE is running a survey among our members to assess how many companies experienced delays in Scientific - [EUCOPE’s response to the call for evidence on the EU Life Sciences Strategy | WHA Resolution on Rare Diseases | EUCOPE meetings | Agenda](https://www.eucope.org/membersonly/eucopes-response-to-the-call-for-evidence-on-the-eu-life-sciences-strategy-wha-resolution-on-rare-diseases-eucope-meetings-agenda/) - Weekly Update EUCOPE’s response to the call for evidence on the EU Life Sciences Strategy As previously announced, EUCOPE published on 17 April its response to the call for evidence on the EU Life Sciences Strategy. The Strategy, a non-legislative initiative, is planned to be published in Q2 2025. We will inform you about future - [Feedback on EUCOPE's recommendations on EU Life Sciences Strategy | EUCOPE's proposal for a new small mid-caps definition | HERA Review / European Preparedness Union Strategy](https://www.eucope.org/membersonly/feedback-on-eucopes-recommendations-on-eu-life-sciences-strategy-eucopes-proposal-for-a-new-small-mid-caps-definition-hera-review-european-preparedness-union-strategy/) - Feedback on EUCOPE's recommendations on EU Life Sciences Strategy (deadline: 9 April COB) As announced in last week’s Member Mail, EUCOPE shared its recommendations to the EU Life Sciences Strategy, which we will use to respond to the Commission’s call for evidence. Please, provide feedback by 9 April COB to Stefano romanelli@eucope.org and Guilherme ursini@eucope.org. EUCOPE's - [Invitation to EUCOPE member companies to share their experiences with JSCs and JCAs | Feedback on EUCOPE's recommendations on EU Life Sciences Strategy | EUCOPE meetings | Agenda](https://www.eucope.org/membersonly/invitation-to-eucope-member-companies-to-share-their-experiences-with-jscs-and-jcas-feedback-on-eucopes-recommendations-on-eu-life-sciences-strategy-eucope-meetings-agenda/) - Weekly Updates Invitation to EUCOPE member companies to share their experiences with JSCs and JCAs As we have previously informed you, the Regulation (EU) 2021/2282 on health technology assessment has come into application on 12 January 2025 and going forward any Marketing Authorisation Application for an Advanced Therapy Medicinal Product or new active substance for - [EUCOPE New colleague | EUCOPE EU HTA Workshop | EUCOPE upcoming meetings | Podcasts | Readings](https://www.eucope.org/membersonly/eucope-new-colleague-eucope-eu-hta-workshop-eucope-upcoming-meetings-podcasts-readings/) - Welcome to our new colleague: Guilherme Ursini Guilherme joined EUCOPE as Government Affairs Manager, where he will lead the Environment & Sustainability Working Group and the Health Crisis Management & Preparedness Steering Group. He will also coordinate work on clinical trials and EU industrial policies. REMINDER - SAVE THE DATE Join our workshop to explore - [EUCOPE’s initial assessment of the CMA | EUCOPE EU HTA Workshop (8/05/2025) | EUCOPE upcoming meetings | Readings | Agenda](https://www.eucope.org/membersonly/eucopes-initial-assessment-of-the-cma-eucope-eu-hta-workshop-8-05-2025-eucope-upcoming-meetings-readings-agenda/) - In this edition we inform you aboute EUCOPE’s initial assessment of the CMA, the upcoming EUCOPE EU HTA Workshop (8/05/2025), and upcoming meetings. - [European Commission call for evidence for the EU Life Sciences Strategy | EUCOPE upcoming meetings | Readings | Upcoming events](https://www.eucope.org/membersonly/european-commission-call-for-evidence-for-the-eu-life-sciences-strategy-eucope-upcoming-meetings-readings-upcoming-events/) - In this edition we inform you about the EC call for evidence for the EU Life Sciences Strategy, EUCOPE upcoming meetings, latest readings and upcoming events. - [EC Work Programme 2025 | Critical Medicines Act | EUCOPE’s Proposals for the EU Biotech Act| EUCOPE upcoming meetings | Upcoming events](https://www.eucope.org/membersonly/ec-work-programme-2025-critical-medicines-act-eucopes-proposals-for-the-eu-biotech-act-eucope-upcoming-meetings-upcoming-events/) - In this edition we inform you on the EC Work Programme 2025, the Critical Medicines Act, EUCOPE’s Proposals for the EU Biotech Act, upcoming meetings and events - [EU HTA - JSC | EUCOPE positions on EU Life Sciences Strategy & New Mid-Caps Definition | EUCOPE meetings | Upcoming events](https://www.eucope.org/membersonly/eu-hta-jsc-eucope-positions-on-eu-life-sciences-strategy-new-mid-caps-definition-eucope-meetings-upcoming-events/) - In this edition we inform you about EU HTA - JSC, EUCOPE positions on EU Life Sciences Strategy & New Mid-Caps Definition, EUCOPE meetings, Upcoming events - [EC Competitiveness Strategy | EC call for evidence on CMA | SANT Committee | TEHDAS2 Stakeholder Forum | Upcoming events](https://www.eucope.org/membersonly/ec-competitiveness-strategy-ec-call-for-evidence-on-cma-sant-committee-tehdas2-stakeholder-forum-upcoming-events/) - In this edition we inform you about the EC Competitiveness Strategy, the EC call for evidence on CMA, SANT Committee, TEHDAS2 Stakeholder Forum, Upcoming events - [Warning - fraudulent emails | Understanding the new EU HTA Regulation | EUCOPE webinar update | Upcoming events](https://www.eucope.org/membersonly/warning-fraudulent-emails-understanding-the-new-eu-hta-regulation-eucope-webinar-update-upcoming-events/) - In this edition you may read about Understanding the new EU HTA Regulation, EUCOPE webinar update and upcoming events. - [European Parliament - Committees and intergroups | European Commission's response to EUCOPE high-level letter | Medical Devices - Open consultation | Upcoming events](https://www.eucope.org/membersonly/european-parliament-committees-and-intergroups-european-commissions-response-to-eucope-high-level-letter-medical-devices-open-consultation-upcoming-events/) - In this edition you may read on the EP Committees and intergroups, EC's response to EUCOPE high-level letter, Medical Devices - Open consultation, and upcoming events - [EUCOPE Membership Invoice | Healthcare Chain Institute Survey| PNR/Market Access Working Group Meeting - Follow-up| OMP Working Group | Upcoming events](https://www.eucope.org/membersonly/eucope-membership-invoice-healthcare-chain-institute-survey-pnr-market-access-working-group-meeting-follow-up-omp-working-group-upcoming-events/) - In this edition you may read on EUCOPE Membership Invoice, HCI Survey, PNR/Market Access WG & OMP WG Meetings follow-up and upcoming events - [EU HTA - EUCOPE Webinar | Medical Devices - EC Open Consultation | OMP & C&G Therapy WGs 2025 Schedule | Upcoming events](https://www.eucope.org/membersonly/eu-hta-eucope-webinar-medical-devices-ec-open-consultation-omp-cg-therapy-wgs-2025-schedule-upcoming-events/) - In this edition we inform you about EU HTA - EUCOPE Webinar | Medical Devices - EC Open Consultation | OMP & C&G Therapy WGs 2025 Schedule | Upcoming events - [EUCOPE Position Paper on AMR | Event recap "What Drives Life Sciences Investment in the EU and the Future Impact of the Pharma Package" | EUCOPE Up-coming meetings | Agenda](https://www.eucope.org/membersonly/eucope-position-paper-on-amr-event-recap-what-drives-life-sciences-investment-in-the-eu-and-the-future-impact-of-the-pharma-package-eucope-up-coming-meetings-agenda/) - In this edition, you may read on EUCOPE position paper on AMR, EUCOPE up-coming meetings, event recap on EU Life Sciences Investment, up-coming events - [European Commission Workshop on Hospital Exemption - follow-up | EUCOPE Up-coming meetings | Events | Readings: EUCOPE & FTI report on EU life sciences investments](https://www.eucope.org/membersonly/european-commission-workshop-on-hospital-exemption-follow-up-eucope-up-coming-meetings-events-readings-eucope-fti-report-on-eu-life-sciences-investments/) - In this edition, you may read on the EC Workshop on Hospital Exemption, EUCOPE Up-coming meetings, events and our latest report on EU life sciences investments - [EUCOPE FTI Launch event | EUCOPE Digital Health WG Meeting | EUCOPE Members Meeting - follow-up | Upcoming events](https://www.eucope.org/membersonly/eucope-fti-launch-event-eucope-digital-health-wg-meeting-eucope-members-meeting-follow-up-upcoming-events/) - In this edition we inform you on: EUCOPE FTI Launch event, EUCOPE Digital Health WG Meeting, EUCOPE Members Meeting - follow-up, Upcoming events - [Medical Technologies FG Meeting | P&R/Market Access WG Meeting | EUCOPE & FTI Launch Event | Rare Disease Moonshot Event](https://www.eucope.org/membersonly/medical-technologies-fg-meeting-pr-market-access-wg-meeting-eucope-fti-launch-event-rare-disease-moonshot-event/) - In this edition we inform you on: Medical Technologies FG Meeting, P&R/Market Access WG Meeting, EUCOPE & FTI Launch Event, Rare Disease Moonshot Event - [Commissioner-designates hearings | EMA Bilateral Meeting | RWE FG Meeting | Cell and Gene Therapy WG Meeting | OMP WG Meeting | Upcoming events](https://www.eucope.org/membersonly/commissioner-designates-hearings-ema-bilateral-meeting-rwe-fg-meeting-cell-and-gene-therapy-wg-meeting-omp-wg-meeting-upcoming-events/) - In this edition we inform you on: Commissioner's hearings, EMA Bilateral Meeting, EUCOPE FG and WG meetings, Upcoming events - [EUCOPE & FTI Launch Event | EUCOPE Paediatric FG Meeting | P&R/Market Access WG | OMP WG Meeting | TRANSFORM Conference](https://www.eucope.org/membersonly/eucope-fti-launch-event-eucope-paediatric-fg-meeting-pr-market-access-wg-omp-wg-meeting-transform-conference/) - In this edition we inform you on: the EUCOPE & FTI Launch Event, EUCOPE Paediatric FG Meeting, P&R/Market Access WG, OMP WG Meeting and the TRANSFORM Conference - [eHealth Stakeholder Group | P&R/Market Access WG | Regulatory WG | OMP WG | European Commissioners’ hearings | Environmental sustainability criteria in HTA | Readings | Agenda](https://www.eucope.org/membersonly/ehealth-stakeholder-group-pr-market-access-wg-regulatory-wg-omp-wg-european-commissioners-hearings-environmental-sustainability-criteria-in-hta-readings-agenda/) - In this edition, you may read on the upcoming EUCOPE WG meetings, EU Commissioners hearings, Environmental criteria in HTA, readings and upcoming events. - [EUCOPE Members Meeting | Scientific Symposium on Advanced Therapy Medicinal Products | EMA SME Info Day | TRANSFORM MEP Interest Group Conference 2024](https://www.eucope.org/membersonly/eucope-members-meeting-scientific-symposium-on-advanced-therapy-medicinal-products-ema-sme-info-day-transform-mep-interest-group-conference-2024/) - In this edition, we inform you on EUCOPE Members Meeting, the Scientific Symposium on ATMPs, the EMA SME Info Day and the TRANSFORM MEP Interest Group Conference 2024 - [MDR Coordination Group Meeting | RWE4Decisions Webinar | RD Moonshot initiative & Euronews event | TRANSFORM MEP Interest Group Conference 2024  ](https://www.eucope.org/membersonly/mdr-coordination-group-meeting-rwe4decisions-webinar-rd-moonshot-initiative-euronews-event-transform-mep-interest-group-conference-2024/) - In this edition, you may read on : MDR Coordination Group Meeting, RWE4Decisions Webinar, RD Moonshot initiative & Euronews event, TRANSFORM MEP Interest Group Conference 2024 - [EUCOPE Guidance document to Technopolis survey | OMP WG Meeting Agenda | EU Elections Workshop](https://www.eucope.org/membersonly/eucope-guidance-document-to-technopolis-survey-omp-wg-meeting-agenda-eu-elections-workshop/) - Dear Members, In this email, you will find some guidance about the Technopolis survey on the EU OMP Regulation as well as additional information about the upcoming OMP Working Group meeting of 24 October and a EUCOPE Workshop on the 2019 EU Elections. Technopolis survey on the EU OMP Regulation As previously reported, the European - [EUCOPE Gene & Cell Therapy WG slides + position paper | next meeting 22 November 12-16.30 CET | GCP for ATMP Consultation](https://www.eucope.org/membersonly/eucope-gene-cell-therapy-wg-slides-position-paper-next-meeting-22-november-12-16-30-cet-gcp-for-atmp-consultation/) - Dear Members of the Gene & Cell Therapy working group, Reflecting on our very last meeting you will find in the following the slides of our 17 September session, the finalised version of our position paper as well as draft comments on the public consultation regarding GCP for ATMPs. The group met a few weeks - [EUCOPE Legal working group meeting - Berlin, 30 November](https://www.eucope.org/membersonly/eucope-legal-working-group-meeting-berlin-30-november/) - Dear Members, Reflecting on the last Legal working group meeting in Zurich, our member Dierks+Company will be hosting the next session on Friday 30 November 11am-4pm at its new Berlin facilities : Helix Hub, Invalidenstr. 113, 10115 Berlin. Kindly find below/attached the agenda: TOP 1 Welcome TOP 2 Reimbursement in the German hospital sector for - [Telematics strategy 2020-2025 - EMA / Industry Stakeholder Meeting on Brexit - CMDh / Industry associations TC on Brexit](https://www.eucope.org/membersonly/telematics-strategy-2020-2025-ema-industry-stakeholder-meeting-on-brexit-cmdh-industry-associations-tc-on-brexit/) - Dear Members, Please find in the following a consultation on a Concept Paper for Telematics Strategy 2020-2025 as well as the link to the presentations of the EMA - Industry Stakeholder meeting on Brexit that took place on 24 September and the meeting minutes of the CMDh stakeholder teleconference on Brexit that took place on 1 October. Further on, - [Slides EUCOPE P&R/Market Access Meeting of 11 September 2018](https://www.eucope.org/membersonly/slides-eucope-pr-market-access-meeting-of-11-september-2018/) - Dear Members, I am very pleased to share with you the presentations of our external speakers of the September P&R/Market Access Working Group. Additionally, you will find an invitation to join the EUCOPE delegation at the next meeting with the health authorities in Denmark (MEDICINRÅDET), scheduled on 7 December. Presentations of EUCOPE’s Market Access / - [Agenda EUCOPE Members Meeting - 9 October 11am-4pm, Brussels](https://www.eucope.org/membersonly/agenda-eucope-members-meeting-9-october-11am-4pm-brussels/) - Dear Members, Following up on yesterday’s invitation to our EUCOPE 10-Year Anniversary Event scheduled for Monday, 8 October from 6.30pm, we are sharing with you the agenda of our Members Meeting, which is taking place the day after the festivities, on Tuesday 9 October 11am-4pm, rue Marie de Bourgogne 58, 1000 Brussels. This will give - [EUCOPE Members Meeting 21 February 2018, 11 am - 4 pm, Brussels - Commission's proposal on HTA cooperation](https://www.eucope.org/membersonly/eucope-members-meeting-21-february-2018-11-am-4-pm-brussels-commissions-proposal-on-hta-cooperation/) - Dear Members, We would like to invite you to attend the next EUCOPE Members Meeting on 21 February at our offices at rue Marie de Bourgogne 58, 1000 Brussels/Belgium between 11 am – 4 pm. The meeting will be preceded by adinner on 16 October at 7 pm at the restaurant Maison du Luxembourg, rue - [Commission publishes proposal on HTA cooperation - EUCOPE Members Meeting 21 February 2018](https://www.eucope.org/membersonly/commission-publishes-proposal-on-hta-cooperation-eucope-members-meeting-21-february-2018/) - Dear Members, Today, the European Commission has published its Proposal for a Regulation on Health Technology Assessment (HTA). Compared to the draft proposal that was leaked earlier this month (please refer to Alexander’s email of 19 January), the official text contains various editorial changes, including a new numbering of the Articles. With respect to the - [WHO Survey on Improving Access to Novel Medicines | Draft note on potential risks of unilateral label extensions in the GPL | P&R/Market Access WG dial-in details & Agenda - 12 June](https://www.eucope.org/membersonly/who-survey-on-improving-access-to-novel-medicines-draft-note-on-potential-risks-of-unilateral-label-extensions-in-the-gpl-pr-market-access-wg-dial-in-details-agenda-12-june/) - With this email we would like to share with you the WHO Europe Survey on Improving Access to Novel Medicines, a draft note on the potential risks of unilateral label extensions in the GPL as well as the dial-in details and agenda for the P&R/Market Access Working Group meeting. 1. WHO Europe Survey on Improving - [EUCOPE Regulatory WG meeting (11 March) | MoCA webinar (15 February) | EHDS Trilogues | New IVDR proposals | Together4RD survey](https://www.eucope.org/membersonly/eucope-regulatory-wg-meeting-11-march-moca-webinar-15-february-ehds-trilogues-new-ivdr-proposals-together4rd-survey/) - In this email, we invite you to the upcoming EUCOPE Regulatory Working Group meeting (11 March) and to the MoCA webinar co-hosted with EURORDIS (15 February), we update you on the EHDS trilogues and on the new Commission’s proposal on the IVDR, we share with you a survey on cooperation between ERNs and industry by - [Draft IA on procedures for JSC on medicinal products for consultation | P&R /MA meeting slides | MDCG meeting| Members Meeting 16/10/24 | | Upcoming meetings & events](https://www.eucope.org/membersonly/draft-ia-on-procedures-for-jsc-on-medicinal-products-for-consultation-pr-ma-meeting-slides-mdcg-meeting-members-meeting-16-10-24-upcoming-meetings-events/) - In this edition inform you on: Members Meeting, Draft IA on procedures for JSC on medicinal products for consultation, P&R /MA meeting slides (18/09/24), MDCG Meeting and the upcoming events. - [EUCOPE Members Meeting | EUCOPE High-level Letter | Commission Survey | TOPRA Symposium | Upcoming meetings & events](https://www.eucope.org/membersonly/eucope-members-meeting-eucope-high-level-letter-commission-survey-topra-symposium-upcoming-meetings-events/) - *** 16/10/24 - EUCOPE Members Meeting*** EUCOPE's Members Meeting will take place on 16 October 2024, 11:00 a.m. – 4:00 p.m. CET in a hybrid form. On this occasion we will have a dedicated afternoon session on Leveraging the Value of Healthcare Data with four distinguished speakers from the EMA, the EU HTA Coordination Group - [New Commissioner | EUCOPE White Paper | Together4RD Workshop | OHE Webinar on drug shortages](https://www.eucope.org/membersonly/new-commissioner-eucope-white-paper-together4rd-workshop-ohe-webinar-on-drug-shortages/) - Weekly updates Health and Animal Welfare Commissioner nominated - 17/09/2024 On 17 September, Commission President Ursula von der Leyen has announced her new college of Commissioners, with Hungarian Oliver Varhelyi nominated as Commissioner for Health and Animal Welfare. Varhelyi’s Mission Letter has been published. The overall objective is to complete the European Health Union, by diversifying supply chains, improving access - [World Health Assembly (WHA) Resolution on Rare Diseases 2025, the European Rare Diseases Research Alliance, EUCOPE upcoming meetings](https://www.eucope.org/membersonly/world-health-assembly-wha-resolution-on-rare-diseases-2025-the-european-rare-diseases-research-alliance-eucope-upcoming-meetings/) - Towards a World Health Assembly (WHA) Resolution on Rare Diseases 2025 – Public Webinar Co-hosted by Egypt, Qatar, and Spain The webinar, organised by Rare Disease International (RDI) and co-hosted by Egypt, Qatar, and Spain, aimed to emphasise the critical importance of adopting a WHA Resolution on rare diseases (RDs) and to garner international support - [EMA SME Info Day, Rare Disease Moonshot Initiative Publication, EUCOPE High-Level Letter to EU Institutions, EUCOPE - EHDS Webinar](https://www.eucope.org/membersonly/ema-sme-info-day-rare-disease-moonshot-initiative-publication-eucope-high-level-letter-to-eu-institutions-eucope-ehds-webinar/) - EMA SME Info Day On October 18th EMA will host its SME Info Day, with support from EUCOPE. The SME Info Day is a dedicated training event for pharmaceutical SMEs, focusing on regulatory updates, EMA support, and key topics like scientific advice, clinical trials, and new regulations. It offers an opportunity for SMEs to engage - [Pharma competitiveness, EU Biotech Communication, WHO NMP, P&R/Market Access, EHDS](https://www.eucope.org/membersonly/pharma-competitiveness-eu-biotech-communication-who-nmp-pr-market-access-ehds/) - Today we inform you about the following topics: EUCOPE High-Level Letter to EU Institutions on EU pharma competitiveness EUCOPE White Paper on EU Biotech Communication EUCOPE attended the WHO Europe’s Novel Medicines Platform (NMP) consensus building meeting, 2-3 July P&R/Market Access Working Group meeting – 18 September, 3 – 5 pm CET (links to dial-in - [EP ENVI & SANT Committees | EHDS | WODC](https://www.eucope.org/membersonly/ep-envi-sant-committees-ehds-wodc/) - New European Parliament Committees’ Chairs appointed On 26 July, the chair and vice-chairs of the committee on Environment, Public Health and Food Safety (ENVI) and of the subcommittee on Public Health (SANT) have been appointed for the next 2.5 years. Antonio Decaro (S&D, IT) has been elected as ENVI chair. MEPs Esther Herranz García (EPP, ES), Pietro Fiocchi - [Union compulsory license | EU institutions | EU AI Act | Together4RD](https://www.eucope.org/membersonly/union-compulsory-license-eu-institutions-eu-ai-act-together4rd/) - Regulation on a Union compulsory license (CL) The Council adopts their position on the proposal for a union compulsory license. The Council of the EU adopted on 26 June their negotiation mandate on the proposal for a Regulation on a Union compulsory license (CL). Whereas the European Parliament proposal inter alia introduced the requirement to - [EUCOPE general updates | EUCOPE OMP WG slide deck (9 July) | EUCOPE webinar on preparation to new EU HTA (17 July)](https://www.eucope.org/membersonly/eucope-general-updates-eucope-omp-wg-slide-deck-9-july-eucope-webinar-on-preparation-to-new-eu-hta-17-july/) - In this email, we share two general updates about EUCOPE, as well as the slide deck and key takeaways of the recent OMP Working Group (9 July 2024). We also invite you to EUCOPE’s webinar on how to prepare to the new EU HTA requirements as of January 2025 (17 July). New EUCOPE Communications Manager First - [EUCOPE OMP WG & Reg WG meetings (9-10 July) | German Medical Research Act | Hungarian Presidency of the EU | EUCOPE webinar on preparation to new EU HTA (17 July)](https://www.eucope.org/membersonly/eucope-omp-wg-reg-wg-meetings-9-10-july-german-medical-research-act-hungarian-presidency-of-the-eu-eucope-webinar-on-preparation-to-new-eu-hta-17-july/) - In this email, we inform you on the upcoming EUCOPE OMP Working Group (9 July) and Regulatory Working Group (10 July) meetings. We update you on the German Medical Research Act and the healthcare priorities of the Hungarian Presidency of the EU. Finally, we invite you to EUCOPE’s webinar on how to prepare to the new EU HTA - [EUCOPE Members Meeting (19 June) slide deck | EUCOPE upcoming OMP & Reg meetings | EMA guidance on submission of early information by HTDs | Draft HTA IA on EMA cooperation | EPSCO Conclusions on Future EU Health](https://www.eucope.org/membersonly/eucope-members-meeting-19-june-slide-deck-eucope-upcoming-omp-reg-meetings-ema-guidance-on-submission-of-early-information-by-htds-draft-hta-ia-on-ema-cooperation-epsco-conclusions-on-fu/) - In this email, we share the slide deck presented during our Members Meeting on 19 June and we invite you to the upcoming EUCOPE OMP Working Group (9 July) and Regulatory Working Group (10 July) meetings. We inform you about you the recently published EMA guidance on submission of early information by health technology developers - [EUCOPE high-level letter to incoming EU Institutions | EUCOPE P&R / Market Access WG slide deck | EUCOPE webinar on CBHC for ATMPs (24 June) | Together4RD workshop on ERNs-industry partnerships (26 June)](https://www.eucope.org/membersonly/eucope-high-level-letter-to-incoming-eu-institutions-eucope-pr-market-access-wg-slide-deck-eucope-webinar-on-cbhc-for-atmps-24-june-together4rd-workshop-on-erns-industry-partnerships-26-j/) - In this email, we share with and call on you to sign EUCOPE’s high-level letter on EU pharma competitiveness, to be sent to incoming EU Institutions. We also share the slide deck from the last EUCOPE’s P&R / Market Access Working Group meeting (12 June). We invite you to attend EUCOPE’s webinar on cross-border healthcare - [EUCOPE overview of EP elections | EU HTA draft IA on conflicts of interest |EUCOPE webinar on cross-border healthcare for ATMPs (24 June) | IPCEI Med4Cure](https://www.eucope.org/membersonly/eucope-overview-of-ep-elections-eu-hta-draft-ia-on-conflicts-of-interest-eucope-webinar-on-cross-border-healthcare-for-atmps-24-june-ipcei-med4cure/) - In this email, we update you on the European Parliament elections and on the EU HTA draft Implementing Act on conflicts of interest. We invite you to EUCOPE’s webinar on cross-border healthcare for ATMPs and we share information about the IPCEI Med4Cure. Elections of the European Parliament: overview and initial takeaways From 6-9 June, the - [EUCOPE Members and General Meetings (19 June) - Urgent action | EUCOPE LSL webinar on cross-border healthcare for ATMPs (24 June) | Commission consultation on EU public procurement](https://www.eucope.org/membersonly/eucope-members-and-general-meetings-19-june-urgent-action-eucope-lsl-webinar-on-cross-border-healthcare-for-atmps-24-june-commission-consultation-on-eu-public-procurement/) - In this email, we ask you to fill the proxy form for the upcoming EUCOPE General Meeting, and let us know whether you will join EUCOPE Members ang General Meetings (19 June). We invite you to episode 6 of Life Science Lectures webinar on cross-border healthcare for ATMPs (24 June). Finally, we share an update - [EUCOPE Members Meeting (19 June) | Council Conclusions on Single Market and Industrial Policy | EUCOPE LSL webinar on EU HTA (3 June) | EURORDIS Open Letter #Act4Rare2024 | Together4RD workshop on ERN-industry partnerships (26 June)](https://www.eucope.org/membersonly/eucope-members-meeting-19-june-council-conclusions-on-single-market-and-industrial-policy-eucope-lsl-webinar-on-eu-hta-3-june-eurordis-open-letter-act4rare2024-together4rd-workshop-on-ern/) - In this email, we remind you of the upcoming EUCOPE Members Meeting (19 June) and of EUCOPE LSL webinar on EU HTA (3 June). Moreover, we update you on the Council Conclusions on the future of the single market and on the future of industrial policy. We also invite you to sign EURORDIS Open Letter - [EUCOPE OMP Working Group (9 July) | EUCOPE signs EURORDIS Open Letter at ECRD | Commission Communication on EU Health Union | World EPA Congress 2025](https://www.eucope.org/membersonly/eucope-omp-working-group-9-july-eucope-signs-eurordis-open-letter-at-ecrd-commission-communication-on-eu-health-union-world-epa-congress-2025/) - In this email, we invite you to the upcoming EUCOPE OMP Working Group meeting (9 July) and we inform you that we signed EURORDIS Open Letter at ECRD 2024. Moreover, we share the Commission Communication on the European Health Union and the invite you to the World EPA Congress 2025. EUCOPE OMP Working Group – - [EUCOPE Regulatory Working Group (10 July) | LSL webinar episode 5: EU HTA (3 June) | Joint industry paper on health biotech](https://www.eucope.org/membersonly/eucope-regulatory-working-group-10-july-lsl-webinar-episode-5-eu-hta-3-june-joint-industry-paper-on-health-biotech/) - In this email, we invite you to the upcoming EUCOPE Regulatory Working Group meeting on 10 July, and to join EUCOPE Life Science Lectures (LSL) webinar on the EU HTA and how JCAs can support access to OMPs (on 3 June). We also share the joint industry paper on health biotech that we’re currently working - [Invitation EUCOPE Members and General Meeting, 19 June 2024, 11 a.m. - 4 p.m. CET](https://www.eucope.org/membersonly/invitation-eucope-members-and-general-meeting-19-june-2024-11-a-m-4-p-m-cet/) - We would like to invite you to the next EUCOPE Members Meeting and the annual General Meeting which will take place on 19 June 2024, 11:00 a.m. – 4:00 p.m. CET in a hybrid form (at our offices in Rue Marie de Bourgogne 58, 1000 Brussels/Belgium – connecting details attached). Between the Members Meeting’s morning - [EUCOPE P&R / Market Access Working Group meeting (12 June) | EU HTA: survey on JSC slots | EUCOPE podcast on GPL | European Healthcare & Life Sciences Investor Symposium](https://www.eucope.org/membersonly/eucope-pr-market-access-working-group-meeting-12-june-eu-hta-survey-on-jsc-slots-eucope-podcast-on-gpl-european-healthcare-life-sciences-investor-symposium/) - In this email, we share the invite and draft agenda for the upcoming EUCOPE P&R / Market Access Working Group meeting (12 June, h15.00-17.00 CET), as well as the latest EUCOPE’s podcast, discussing the revision of the General Pharmaceutical Legislation (GPL). Moreover, we update you on the EU HTA survey on the slots for JSC - [EUCOPE White Paper on Joint Procurement | DG SANTE Report on Cross-Border Healthcare | EU HTA Regulation: Member States agreement on the draft implementing Act on JCA of medicinal products | EUCOPE Communications](https://www.eucope.org/membersonly/eucope-white-paper-on-joint-procurement-dg-sante-report-on-cross-border-healthcare-eu-hta-regulation-member-states-agreement-on-the-draft-implementing-act-on-jca-of-medicinal-products-eucope-co/) - In this email, we share the pre-final version of EUCOPE White Paper on Joint Procurement, a summary of DG SANTE Report on Cross-Border Healthcare, an update on the draft implementing Act on JCA of medicinal products, and we inform you about some of EUCOPE’s communications activities. EUCOPE White Paper on Joint Procurement We have drafted - [EUCOPE Townhall meeting: slide deck | Parliament adopts EHDS | Launch of Critical Medicines Alliance | EUCOPE P&R / MA Working Group meeting (12 June) | RD Moonshot recommendations](https://www.eucope.org/membersonly/eucope-townhall-meeting-slide-deck-parliament-adopts-ehds-launch-of-critical-medicines-alliance-eucope-pr-ma-working-group-meeting-12-june-rd-moonshot-recommendations/) - In this email, we share the slide deck of the Townhall meeting (on 23 April) and the latest recommendations on translational research from the RD Moonshot. We update you on the EHDS (which the European Parliament formally adopted) and on the launch of the Critical Medicines Alliance. Finally, we inform you of the new date - [EUCOPE Townhall meeting (23 April) | EUCOPE Hospital Exemption position paper | Letta's Report on the EU Single Market | Latham HCLS Market Update](https://www.eucope.org/membersonly/eucope-townhall-meeting-23-april-eucope-hospital-exemption-position-paper-lettas-report-on-the-eu-single-market-latham-hcls-market-update/) - In this email, we share the agenda of the upcoming EUCOPE Townhall meeting (23 April, h15.00-17.00 CET), as well as EUCOPE position paper on Hospital Exemption (HE). Moreover, we update you on health recommendations in Letta’s Report on the EU Single Market, and we share a publication by Latham & Watkins on the healthcare and - [ENVI-LIBE green light EHDS provisional agreement | Joint industry statement on EU HTA IA | Invite to ECRD (15-16 May 2024) | WHO principles on genome data](https://www.eucope.org/membersonly/envi-libe-green-light-ehds-provisional-agreement-joint-industry-statement-on-eu-hta-ia-invite-to-ecrd-15-16-may-2024-who-principles-on-genome-data/) - In this email, we update you on the European Parliament’s ENVI-LIBE endorsement on the EHDS. Moreover, we share the joint industry statement on the EU HTA Implementing Act. Finally, we invite you to join EURORDIS 12th ECRD Conference (15-16 May 2024) and to contribute to WHO principles for human genome access, use and sharing. ENVI-LIBE - [European Parliament adopts reports on Revision of General Pharmaceutical Legislation - EUCOPE's Assessment & Statement](https://www.eucope.org/membersonly/european-parliament-adopts-reports-on-revision-of-general-pharmaceutical-legislation-eucopes-assessment-statement/) - In this email, we update you on the European Parliament’s vote on the Revision of the General Pharmaceutical Legislation, and we share our assessment and statement. Find also enclosed the calendar’s invite to the Townhall meeting on 23 April. European Parliament reports on the Revision of the General Pharmaceutical Legislation + EUCOPE assessment and press - [EUCOPE membership in the Critical Medicines Alliance | EUCOPE's response to EU HTA IA | Council position on future of EU health | KCE study on UMN](https://www.eucope.org/membersonly/eucope-membership-in-the-critical-medicines-alliance-eucopes-response-to-eu-hta-ia-council-position-on-future-of-eu-health-kce-study-on-umn/) - In this email, we announce we have been selected as members of the Critical Medicines Alliance, we update you on the Council’s discussions on the future of EU health, we share our response to the public consultation on the EU HTA Implementing Act (IA) and a study from KCE on unmet medical needs (UMN). - [EUCOPE OMP WG slide deck (21 March) | EUCOPE Townhall meeting 3.0 (23 April 2024)](https://www.eucope.org/membersonly/eucope-omp-wg-slide-deck-21-march-eucope-townhall-meeting-3-0-23-april-2024/) - In this email, we share the slide deck and key takeaways of the recent OMP Working Group (21 March 2024). We also invite you to join the upcoming EUCOPE Townhall meeting (23 April 2024, h15.00-17.00 CET). Slide deck and key takeaways: EUCOPE OMP working group meeting (21 March 2024) On 21 March, EUCOPE hosted - [EU Institutions agree on EHDS | EU Commission's Biotech Initiative | EUCOPE P&R / MA WG slide deck (28 Feb)](https://www.eucope.org/membersonly/eu-institutions-agree-on-ehds-eu-commissions-biotech-initiative-eucope-pr-ma-wg-slide-deck-28-feb/) - In this email, we share updates about the agreement the EU Institutions reached on the EHDS and about the European Commission’s Biotech Initiative, as well as the slides of the last P&R / Market Access working group meeting (28 February). EU Institutions reach a deal on the European Health Data Space (EHDS) Negotiators from the - [ENVI vote on the EU Pharma Package - EUCOPE's Assessment & Statement](https://www.eucope.org/membersonly/envi-vote-on-the-eu-pharma-package-eucopes-assessment-statement/) - A few moments ago, the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) adopted their reports on the two proposals that form the EU Pharmaceutical Package with 67 votes in favour, 7 abstentions and 6 votes against. Note: this is not the final step in the process, the Plenary must adopt the - [EUCOPE OMP Working Group meeting (21 March) | EP adopts Compulsory Licensing | EMA webinar (19 March) | JARDIN initiative](https://www.eucope.org/membersonly/eucope-omp-working-group-meeting-21-march-ep-adopts-compulsory-licensing-ema-webinar-19-march-jardin-initiative/) - In this email, we share the final reminder and the agenda of the EUCOPE OMP Working Group meeting (21 March), we inform you about the European Parliament’s Plenary vote on the Compulsory Licensing Regulation, we invite you to an EMA webinar co-hosted by EUCOPE (19 March) and we share an update on the Commission’s JARDIN - [EU HTA Regulation: 1st draft Implementing Act on JCA of medicinal products has been published for consultation | EU HTA Regulation Task Force meeting, 19 March between 3 - 4 pm CET](https://www.eucope.org/membersonly/eu-hta-regulation-1st-draft-implementing-act-on-jca-of-medicinal-products-has-been-published-for-consultation-eu-hta-regulation-task-force-meeting-19-march-between-3-4-pm-cet/) - With this email we would like to share with you the 1st draft ‘Implementing Act on Joint Clinical Assessments (JCA) of medicinal products’ that was published today, and which lays down the detailed procedures and timelines for the EU HTA procedure of Regulation (EU) 2021/2282 on health technology assessment. Please find the relevant documents attached - [EUCOPE Members Meeting (20 February) slide deck | EUCOPE OMP Working Group meeting (21 March) | EP adopts Unitary SPC | Rare Disease Forum 2024 (16 April)](https://www.eucope.org/membersonly/envi-members-meeting-20-february-slide-deck-eucope-omp-working-group-meeting-21-march-ep-adopts-unitary-spc-rare-disease-forum-2024-16-april/) - In this email, we share the slide deck presented during our Members Meeting on 20 February, we invite you to the upcoming EUCOPE OMP Working Group meeting (21 March), we inform you about the European Parliament’s Plenary vote on the SPC legislation, and we share an invite to the Rare Disease Forum (16 April). - [JURI committee position on the EU Patent Package | Survey on pharmaceutical clawbacks](https://www.eucope.org/membersonly/juri-committee-position-on-the-eu-patent-package-survey-on-pharmaceutical-clawbacks/) - In this email, we share an update on the position of the European Parliament’s JURI committee on the EU Patent Package and a survey on pharmaceutical clawbacks in Europe. European Parliament proposals on EU Patent Package advance to plenary vote: Recast SPC Regulation, Unitary SPC Regulation and Regulation on compulsory licensing for crisis managementAs we - [EUCOPE OMP Working Group meeting (21 March) | ENVI vote on SoHO | EMA webinar (19 March)](https://www.eucope.org/membersonly/eucope-omp-working-group-meeting-21-march-envi-vote-on-soho-ema-webinar-19-march/) - In this email, we invite you to the upcoming EUCOPE OMP Working Group meeting (21 March), we inform you about the ENVI vote on the SoHO Regulation and the next steps, we share an invite to an EMA webinar (19 March). EUCOPE OMP Working Group – 21 March (h10.00-12.30 CET) The first EUCOPE OMP - [EUCOPE-EURORDIS MoCA Webinar (15 February) | Irish Ministry of Health's survey on GPL (incentives)](https://www.eucope.org/membersonly/eucope-eurordis-moca-webinar-15-february-irish-ministry-of-healths-survey-on-gpl-incentives/) - In this email, we share two short updates, about the upcoming EUCOPE-EURORDIS MoCA webinar (15 February) and the survey for stakeholders’ input on incentives in the revision of the pharmaceutical legislation by the Irish Ministry of Health. MoCA webinar for EUCOPE members (15 February, h10.00-11.30 CET) As mentioned in previous emails, on 15 February (h10.00-11.30 - [EUCOPE P&R/Market Access Working Group meeting (28 February) | EUCOPE Members Meeting and Regulatory Working Group | HERA public consultation | Together4RD survey | E-mails system](https://www.eucope.org/membersonly/eucope-pr-market-access-working-group-meeting-28-february-eucope-members-meeting-and-regulatory-working-group-hera-public-consultation-together4rd-survey-e-mails-system/) - In this email, we share with you the connection details and agenda of the upcoming P&R/Market Access Working Group meeting, the dates and times of various upcoming EUCOPE meetings (MoCA webinar, Members Meeting, Regulatory Working Group, OMP Working Group). We also seek for your feedback to EUCOPE’s draft response to the HERA public consultation and - [EUCOPE meetings | EC report on pharmaceutical competition | Upcoming events | IRDiRC paper on drug repurposing](https://www.eucope.org/membersonly/eucope-meetings-ec-report-on-pharmaceutical-competition-upcoming-events-irdirc-paper-on-drug-repurposing/) - In this email, we share with you dates and times of various upcoming EUCOPE meetings (Members Meeting, P&R / Market Access Working Group, OMP Working Group), the European Commission’s Report on competition enforcement in the pharmaceutical sector 2018-2022, a series of upcoming events that EUCOPE joins or supports, and IRDiRC paper on drug repurposing for - [Germany: MoH presents Draft Medical Research Act](https://www.eucope.org/membersonly/germany-moh-presents-draft-medical-research-act/) - The German Ministries for Health and for the Environment have put forward a Draft Bill (“Referentenentwurf”) of the so called Medical Research Act (Medizinforschungsgesetz). Please note that a draft bill is only the first step in the legislative process. In the coming weeks the relevant stakeholders will be consulted before the coordination with other ministries - [Invitation EUCOPE Members Meeting, 20 February 2024, 11 a.m. - 4 p.m. CET, Brussels & Remote Access](https://www.eucope.org/membersonly/invitation-eucope-members-meeting-20-february-2024-11-a-m-4-p-m-cet-brussels-remote-access/) - We would like to invite you to the next EUCOPE Members Meeting which will take place on 20 February 2024, 11:00 a.m. – 4:00 p.m. CET in a hybrid form (EUCOPE offices, Rue Marie de Bourgogne 58, 1000 Brussels, connecting details attached). Please find the agenda attached for your information. The meeting will be preceded by - [EUCOPE selected in CASoHO | Critical Medicines Alliance | HERA survey | RD Moonshot publication](https://www.eucope.org/membersonly/eucope-selected-in-casoho-critical-medicines-alliance-hera-survey-rd-moonshot-publication/) - In this email, we inform you that EUCOPE has been selected in the CASoHO, and we share an update on the Critical Medicines Alliance, an invite to participate to the HERA survey and the latest publication of the RD Moonshot. We’d also like to welcome My Lan Nha Khu, who has recently joined EUCOPE as - [EUCOPE-Sidley event (7-8 February) | EP Magazine article | RD Moonshot update](https://www.eucope.org/membersonly/eucope-sidley-event-7-8-february-ep-magazine-article-rd-moonshot-update/) - In this email, we share an invitation to an event co-hosted by Sidley and EUCOPE on 7-8 February, an article on the EP Magazine written by MEP Kympouropoulos in partnership with EUCOPE and an update about the Rare Disease Moonshot. But first of all, we’d like to welcome Dr Seán Byrne, who has recently joined - [Revision of the pharmaceutical legislation | EP non-legislative reports | Recap #LifeScienceLectures ep. 4](https://www.eucope.org/membersonly/revision-of-the-pharmaceutical-legislation-ep-non-legislative-reports-recap-lifesciencelectures-ep-4/) - In this email, we share a final update of the year on the revision of the pharmaceutical legislation, short developments about non-legislative initiatives on health adopted by the European Parliament, as well as the recap of the last episode of #LifeScienceLectures. Revision of the pharmaceutical legislation: state of play The revision of the EU - [WHO Europe's Access to Novel Medicines Platform | Belgian Presidency of the EU | New Polish Government](https://www.eucope.org/membersonly/who-europes-access-to-novel-medicines-platform-belgian-presidency-of-the-eu-new-polish-government/) - In this email, we update you on WHO Europe’s Access to Novel Medicines platform, and we share the latest developments about the upcoming Belgian Presidency of the EU and the new Polish government. Update on WHO Europe’s Access to Novel Medicines Platform: Establishment of the Working Groups and proposed activities As we have informed - [EHDS adopted in EP | EMA Fee Regulation | Union List of Critical Medicines | P&R / MA WG slides (29 Nov)](https://www.eucope.org/membersonly/ehds-adopted-in-ep-ema-fee-regulation-union-list-of-critical-medicines-pr-ma-wg-slides-29-nov/) - In this email, we share updates from this week’s Plenary votes, where the European Parliament adopted its position on the EHDS and the text on the EMA FEE Regulation. Moreover, we share an update on the Union List of Critical Medicines and the slides from the P&R / Market Access Working Group of 29 November. - [Germany: Strategy Paper on the Improvement of the Framework Conditions for the Pharmaceutical Sector](https://www.eucope.org/membersonly/germany-strategy-paper-on-the-improvement-of-the-framework-conditions-for-the-pharmaceutical-sector/) - The German Ministry of Health has released its Strategy Paper on the improvement of the framework conditions for the pharmaceutical sector (copy in German attached). This document describes, inter alia, the cornerstones of a new bill, the so called Medical Research Act (Medizinforschungsgesetz). The German government’s intention is to bring large-scale pharmaceutical research and production - [EHDS Council position | MEPs amendments Pharmaceutical Package | ENVI meeting | Life Science Lectures #4](https://www.eucope.org/membersonly/ehds-council-position-meps-amendments-pharmaceutical-package-envi-meeting-life-science-lectures-4/) - In this email, we share an update on the Council compromise on EHDS, an overview of the MEPs’ amendments to the Pharmaceutical Package, the key takeaways from the ENVI debate on 4 December and a reminder to join EUCOPE’s #LifeScienceLectures episode 4 about leveraging early advice opportunities in EU HTA. The Council adopted compromise - [EHDS committees' vote | EPSCO meeting | ITRE debate on Pharma Package](https://www.eucope.org/membersonly/ehds-committees-vote-epsco-meeting-itre-debate-on-pharma-package/) - In this email, we share an update on the vote on EHDS that took place in ENVI and LIBE committees on 28 November, the key takeaways from the EPSCO meeting on 30 November and from ITRE debate on the Pharmaceutical Package of 28 November. ENVI and LIBE joint committee adopt compromise amendments to the European - [EUCOPE OMP Working Group slides (21 November) | Ireland survey on shortages | Life Science Lectures #4](https://www.eucope.org/membersonly/eucope-omp-working-group-slides-21-november-ireland-survey-on-shortages-life-science-lectures-4/) - In this email, we share a recap and the slides of the last 2023 OMP Working Group meeting (21 November), the Irish survey on security of supply and shortages and an invitation to join EUCOPE’s #LifeScienceLectures episode 4 about leveraging early advice opportunities in EU HTA. Slide deck: OMP Working Group Meeting (21 November - [EUCOPE Regulatory Working Group (28 November) | EUCOPE OMP Working Group (21 November) | Recap event 'economic off-label use' | German strategy paper on pharmaceutical sector | EMA event on SMEs (24 November)](https://www.eucope.org/membersonly/eucope-regulatory-working-group-28-november-eucope-omp-working-group-21-november-recap-event-economic-off-label-use-german-strategy-paper-on-pharmaceutical-sector-ema-event-on-smes/) - In this email, we share an invitation to the upcoming Regulatory Working Group meeting (28 November), the last reminder of the OMP Working Group meeting (21 November), an update on the strategy paper for the German pharmaceutical sector, a recap of the event on ‘economic off-label use of medicines’ on 14 November and the invite - [EUCOPE OMP Working Group (21 November) | ITRE draft opinions Pharma Package | Italian Budget Law | Event in the EP (15 November)](https://www.eucope.org/membersonly/eucope-omp-working-group-21-november-itre-draft-opinions-pharma-package-italian-budget-law-event-in-the-ep-15-november/) - Today, we share an invitation to the upcoming OMP Working Group meeting (21 November), an overview of ITRE draft opinions on the Pharmaceutical Package, an update on the Italian Budget Law, the invite to an event co-hosted by EUCOPE in the European Parliament (15 November). EUCOPE OMP Working Group – 21 November (h11.15 – - [EUCOPE P&R / Market Access Working Group (29 November) | ENVI debate on the Pharma Package | GOLUP event in the EP (14 November) | EUPATI training initiative](https://www.eucope.org/membersonly/eucope-pr-market-access-working-group-29-november-envi-debate-on-the-pharma-package-golup-event-in-the-ep-14-november-eupati-training-initiative/) - In this email, we share an invitation to the upcoming Pricing & Reimbursement / Market Access Working Group meeting (29 November), an update on the discussions in ENVI on the Pharmaceutical Package, the invite to an event co-hosted by EUCOPE in the European Parliament (14 November) and an initiative by EUPATI. Invitation: P&R/Market Access - [EUCOPE Members Meeting slide deck (18 October) | Commission Communication on medicine shortages | EU HTA Task Force meeting (15 November) |OMP Working Group meeting (21 November) | Conference on Cell & Gene Therapy](https://www.eucope.org/membersonly/eucope-members-meeting-slide-deck-18-october-commission-communication-on-medicine-shortages-eu-hta-task-force-meeting-15-november-omp-working-group-meeting-21-november-conference-on-cell/) - In this email, we share the slides of EUCOPE Members Meeting (on 18 October), an overview of the Commission’s Communication on addressing medicine shortages, the invitation to the EU HTA Task Force (15 November) and to the OMP Working Group (21 November), as well as the invite to a Conference on Cell & Gene Therapy - [EUCOPE Digital Health Working Group (9 November) | EMA request on supply and availability](https://www.eucope.org/membersonly/eucope-digital-health-working-group-9-november-ema-request-on-supply-and-availability/) - In this email, we share the invite to the upcoming Digital Health Working Group meeting (9 November), and the EMA request about potential issues with supply and medicines availability related to the current situation in Israel. EUCOPE Digital Health Working Group meeting (9 November, 15:00 – 17:00 CET) EUCOPE’s next Digital Health Working Group - [EUCOPE Members Meeting (18 October) | EUCOPE assessment: EP Reports Pharma Package | P&R / MA Working Group slides](https://www.eucope.org/membersonly/eucope-members-meeting-18-october-eucope-assessment-ep-reports-pharma-package-pr-ma-working-group-slides/) - In this email, we share the final agenda of EUCOPE Members Meeting (on 18 October), a first analysis of the European Parliament’s Reports on the Pharma Package, the slides from the last P&R / Market Access Working Group. Reminder: EUCOPE Extraordinary General Meeting and Members Meeting, 18 October This is a final reminder - [EUCOPE General Meeting (18 October) | EP Reports Pharma Package | EC first HTA Implementing Act JCA | OMP Working Group (21 November)](https://www.eucope.org/membersonly/eucope-general-meeting-18-october-ep-reports-pharma-package-ec-first-hta-implementing-act-jca-omp-working-group-21-november/) - In this email, we share an urgent request to fill the proxy for EUCOPE General Meeting (on 18 October), and updates on the European Parliament’s Reports on the Pharma Package, the first Commission’s HTA Implementing Act on JCA, the upcoming OMP Working Group (21 November). Urgent Reminder: Proxy Extraordinary General Meeting – 18 October - [EUCOPE General Meeting (18 October) | EU Variation Framework | COMPET meeting | EMA fees](https://www.eucope.org/membersonly/eucope-general-meeting-18-october-eu-variation-framework-compet-meeting-ema-fees/) - In this email, we share updates on the upcoming EUCOPE General Meeting (on 18 October), EUCOPE feedback to the Commission’s consultation on the EU Variation Framework, the recap of the COMPET meeting discussing the EU Pharmaceutical Package, and an update on the EMA Fees Regulation. Urgent Reminder: Proxy Extraordinary General Meeting 18 Oct This is - [Pharma Package Kick-Off | LSL #3 Recap | Together4RD Paper | SoHO | ACCESS Europe23](https://www.eucope.org/membersonly/pharma-package-kick-off-lsl-3-recap-together4rd-paper-soho-access-europe23/) - In this email, we share updates on the EU Pharma Package translations, the recent position statement from Together4RareDiseases, the event recap from the third episode of our #LifeScienceLectures series, an update on the adoption of the SoHO text and an invite to ACCESS Europe 23 with a 50% discount code. European Parliament kicks off - [Invitation EUCOPE Extraordinary General Meeting/Members Meeting 18 October 2023, Brussels](https://www.eucope.org/membersonly/invitation-eucope-extraordinary-general-meeting-members-meeting-18-october-2023-brussels/) - Dear Members, With this email we would like to invite you to the Extraordinary EUCOPE General Meeting and Members Meeting which will take place on 18 October 2023. The Extraordinary General Meeting takes place between 11:30 a.m. and 12:30 p.m. CET followed by the Members Meeting between 12:30 p.m. and 4 p.m. CET. Both meetings - [MDR/IVDR Focus Group | PRMA WG | ECGP op-ed | DIA HTA Forum](https://www.eucope.org/membersonly/mdr-ivdr-focus-group-prma-wg-ecgp-op-ed-dia-hta-forum/) - Dear EUCOPE Members, In this Members Mail, you will find an update about our new MDR/IVDR Focus Group and its next meeting, a reminder about the upcoming virtual P&R/Market Access WG meeting, a new op-ed by the EUCOPE-led ECGP coalition and an invitation to the upcoming DIA HTA Forum in Brussels. By the way, if - [RWE WG | Transparency Directive | Parliament article | WODC Europe](https://www.eucope.org/membersonly/rwe-wg-transparency-directive-parliament-article-wodc-europe/) - In this Members Mail, we share our plans to set up a new Real-World Evidence (RWE) Working Sub-Group, EUCOPE’s response to the Transparency Directive survey, the latest article by Alexander Natz in The Parliament magazine and an invitation to the World Orphan Drug Congress Europe, with complimentary tickets for EUCOPE members. Establishing a potential RWD/E - [Pharma Package Position Paper | Life Science Lectures #3 | Blog on Trans-Atlantic Pharma | World Cancer Series](https://www.eucope.org/membersonly/pharma-package-position-paper-life-science-lectures-3-blog-on-trans-atlantic-pharma-world-cancer-series/) - In this Members Mail, we share our final Position Paper on the EU Pharmaceutical Package, an invitation to the third episode of our Life Science Lectures webinar series, a new blog by on the future of Pharma in the US and EU and an invitation to the World Cancer Series Europe. We’re also looking to - [P&R WG Meeting | Study on Beating Cancer Plan | RWE Podcast](https://www.eucope.org/membersonly/pr-wg-meeting-study-on-beating-cancer-plan-rwe-podcast/) - In this email, we share the details of our upcoming P&R/Market Access Working Group Meeting, a study on the implementation of Europe’s Beating Cancer Plan and our latest podcast on real-world evidence (RWE). P&R/Market Access Working Group Meeting (27 September | 15:00 – 17:00 CET) The next meeting of the Pricing & Reimbursement/Market Access Working - [Transparency Directive Survey | SoHO reflections | EU ALS event](https://www.eucope.org/membersonly/transparency-directive-survey-soho-reflections-eu-als-event/) - In this Members’ Mail, we share the Transparency Directive Public Survey from DG SANTE, offer our first reflections on the amended SoHO report and invite you to an upcoming event hosted by the EU ALS Coalition. Survey: DG SANTE launches Transparency Directive Public Survey Following the workshop hosted on 29 June, DG SANTE launched a - [For your review: Draft EUCOPE Articles of Association and Internal Rules](https://www.eucope.org/membersonly/for-your-review-draft-eucope-articles-of-association-and-internal-rules/) - Dear Members, As explained at the Members Meeting on 21 June, a change of the Belgian laws governing non-for-profit-organisations required a legal audit and subsequent revision of EUCOPE’s Articles of Association (AoA) and By-laws. Please find the attached revised Articles of Association (hereunder Draft-AoA) and Internal Rules (hereunder Draft-Internal Rules which shall replace the current - [Pharma Package Final Feedback | MDR/IVDR Update | EU Files Op-Ed](https://www.eucope.org/membersonly/pharma-package-final-feedback-mdr-ivdr-update-eu-files-op-ed/) - In this Members Mail, we share the pre-final version of EUCOPE\s feedback to the EU Pharmaceutical Package, an update on the MDR/IVDR transitional provisions as well a new op-ed by Alexander Natz on the impact of the EU Pharma Package on smaller companies. We’d also like to welcome Marcus Droege, who has recently joined EUCOPE - [White Paper on EU Stockpiling | HTA JSCs | EMA fees | HUMN Podcast](https://www.eucope.org/membersonly/white-paper-on-eu-stockpiling-hta-jscs-ema-fees-humn-podcast/) - In this email, we share the release of our recent White Paper on EU-wide stockpiling, an update on Joint Scientific Consultations, a note on EMA fees and our latest podcast on the revision of the OMP Regulation. White Paper: EU-wide Stockpiling: Better Preparedness for Cross-Border Health Threats On 12 July 2023, EUCOPE's HERA Steering Group - [EU Patent Package | HERA White Paper | MoCA Paper | Transparency Workshop](https://www.eucope.org/membersonly/eu-patent-package-hera-white-paper-moca-paper-transparency-workshop/) - In this Members’ Mail, we share our draft response to the Commission’s consultations on EU Patent Package, our recent HERA White Paper for feedback, a recent publication on MoCA (Mechanism of Coordinated Access to Orphan Medicinal Products), and an update on the DG SANTE Transparency Directive workshop. Draft EUCOPE response to the European Commission’s consultations - [EUCOPE Members & General Meeting | P&R WG Slides | Rare Disease Partnership](https://www.eucope.org/membersonly/eucope-members-general-meeting-pr-wg-slides-rare-disease-partnership/) - In this email, we share the invitation for our upcoming Members & General Meeting on 21 June, the slidedeck from last week’s P&R/Market Access Working Group meeting and an opportunity to contribute to the Rare Disease Partnership Consultation. Invitation: EUCOPE Members & General Meeting (21 June 2023 | 11:00 – 16:00 CET | hybrid) We - [Access to Novel Medicines Platform | Life Science Lectures #1](https://www.eucope.org/membersonly/access-to-novel-medicines-platform-life-science-lectures-1/) - Dear EUCOPE Members, In this email, we share information regarding the launch of WHO Europe’s “Access to Novel Medicines Platform” and a last reminder for next week’s inaugural edition of our Life Science Lecture webinar series. WHO Europe launches the “Access to Novel Medicines Platform” and is seeking stakeholders’ participation in three technical working groups - [EUCOPE: P&R / Market Access WG meeting (25 may) | OMP WG meeting (20 June) | Patent Package public consultation | MDR update](https://www.eucope.org/membersonly/eucope-pr-market-access-wg-meeting-25-may-omp-wg-meeting-20-june-patent-package-public-consultation-mdr-update/) - Dear Members, In this email, we share a reminder of the P&R / Market Access working group meeting (25 May, virtual), an invite to join the OMP working group meeting (20 June, hybrid), a call to provide feedback on the patent package and an update on MDR transitional provisions. Market Access Working Group meeting – 25 - [Town Hall 2.0 - Slidedeck](https://www.eucope.org/membersonly/town-hall-2-0-slidedeck/) - EUCOPE Town Hall 2.0 - Slidedeck - [EMA Paper | P&R WG | RWE4Decisions | Life Science Lectures #1](https://www.eucope.org/membersonly/ema-paper-pr-wg-rwe4decisions-life-science-lectures-1/) - In this email, we share an update on the recent EMA reflection paper for single arm trials, a call for documents related to PLEG from RWE4Decisions plus invitations to the upcoming P&R/Market Access Working Group and the first episode of our new webinar series – Life Science Lectures. EMA consultation: Reflection paper on establishing efficacy - [European Commission publishes "EU patent package", proposes to introduce a Union compulsory license for crises management along with an EU-wide unitary SPC and a unified SPC grant procedure](https://www.eucope.org/membersonly/european-commission-publishes-eu-patent-package-proposes-to-introduce-a-union-compulsory-license-for-crises-management-along-with-an-eu-wide-unitary-spc-and-a-unified-spc-grant-procedure/) - Dear Members, With this email we would like to share with you the recently published European Commission proposals to introduce a Union compulsory license for crises management and an EU-wide unitary SPC and a unified SPC grant procedure. As we have informed you previously, the proposals form part of the ‘EU patent package’, outlined in - [Publication of EU Pharma Package - EUCOPE's Assessment & Statement](https://www.eucope.org/membersonly/publication-of-eu-pharma-package-eucopes-assessment-statement/) - Dear EUCOPE Members, The day has finally arrived. The European Commission has published its draft overhaul of the pharmaceutical legislation today. In this email, we highlight the key things you need to know, our official statement on the legislation and a reminder to register for next week’s virtual Town Hall 2.0, where we’ll discuss our - [SANT Meeting | Town Hall 2.0 | HUMN Workshop | PB Op-ed](https://www.eucope.org/membersonly/sant-meeting-town-hall-2-0-humn-workshop-pb-op-ed/) - Apologies for the longer email this week but we have much to share. Below, you’ll find a brief recap of this morning’s first official SANT Committee meeting, two invitations to upcoming EUCOPE events – the virtual Town Hall 2.0 and hybrid Workshop on (H)UMN & Launch – plus we share the latest op-ed in PharmaBoardroom - [MDR/IVDR Podcast | OMP WG Slides | #BreakTheBubble](https://www.eucope.org/membersonly/mdr-ivdr-podcast-omp-wg-slides-breakthebubble/) - In this email, we share our latest Sounds of Science podcast on MDR/IVDR amendments, the slides from the latest OMP Working Group meeting and an invite to the upcoming #BreaktheBubble event from Evoke Incisive Health. Sounds of Science Podcast #15 – MDR/IVDR Amendments: Implications for medical device companies and patients The Medical Devices Regulation (MDR) - [PRIME update | EMA workshop | C> Summit](https://www.eucope.org/membersonly/prime-update-ema-workshop-cgt-summit/) - In this email, we share an update on the new features to the PRIME scheme, the upcoming EMA multi-stakholder workshop and a final reminder about The Economist’s Cell & Gene Therapy Summit. New features further strengthen Priority Medicines scheme (PRIME) EMA introduces a number of new features to the PRIority Medicines (PRIME) scheme to strengthen - [New date for Pharma Package | OMP WG Agenda | Council Conclusions | Call for Podcast Guests](https://www.eucope.org/membersonly/new-date-for-pharma-package-omp-wg-agenda-council-conclusions-call-for-podcast-guests/) - In this email, we share an update on the new date for the revision of the pharmaceutical legislation, a final reminder for next week’s OMP Working Group meeting, recent conclusions by the European Council and a call for our members to participate in an external podcast series. New date for pharmaceutical legislation proposal set for - [Pharma Package Delay | MDR/IVDR | FORUM Seminar | OMP WG](https://www.eucope.org/membersonly/pharma-package-delay-mdr-ivdr-forum-seminar-omp-wg/) - Dear Members, In this email, we share details regarding the delay of the EU Pharma Package, an update on the extension of the rules of the MDR/IVDR, an invitation to a German seminar and a reminder about the upcoming OMP Working Group Meeting. EU Pharmaceutical legislation delayed – again The publication date of the much-anticipated - [EUCOPE CTR Survey | US-EU Innovation Podcast | OD Expert Workshop | Knights for Rare](https://www.eucope.org/membersonly/eucope-ctr-survey-us-eu-innovation-podcast-od-expert-workshop-knights-for-rare/) - In this email, we share our new and updated survey on the Clinical Trial Regulation (CTR), our latest podcast on trans-Atlantic innovation with our American partners, and invitations to two upcoming events next week. EUCOPE Survey on the EU Clinical Trial Regulation EUCOPE is running a 3-minute survey among our members to calculate how many - [Town Hall Slidedeck | MDR\IVDR | OD Expert Group Workshop | OMP WG](https://www.eucope.org/membersonly/town-hall-slidedeck-mdrivdr-od-expert-group-workshop-omp-wg/) - Before the weekend sets in, we’d like to share the slide deck from our recent Virtual Town Hall, an update on the adopted amendment of the MDR/IVDR, an invite to the upcoming OD Expert Group workshop at the European Parliament and a reminder about next month’s OMP Working Group meeting. Slide deck: EUCOPE Town Hall - [Windsor Framework | CTR Survey | P&R WG Slides | German P&R Event](https://www.eucope.org/membersonly/windsor-framework-ctr-survey-pr-wg-slides-german-pr-event/) - Dear Members, In this week’s mail, we touch upon the new agreement of the Windsor Framework, share our new member survey on the Clinical Trial Regulation, as well as our slides from the recent P&R/Market Access Working Group plus an invitation to next week’s free webinar on the P&R landscape in Germany. Windsor Framework You - [MEPs for RD Strategy | EMA MD Pilot | #BreaktheBubble | Pharmageddon](https://www.eucope.org/membersonly/meps-for-rd-strategy-ema-md-pilot-breakthebubble-pharmageddon/) - With this email, we share updates on the recent MEP call for an EU rare disease strategy, the recently launched EMA pilot to give scientific advice for certain medical devices as well as invitations for two upcoming events: #BreaktheBubble by our new member Evoke Incisive Health and Pharmageddon. MEPs call for EU rare disease strategy - [Inter-service consultation | Rare Disease Day Podcast & Blog](https://www.eucope.org/membersonly/inter-service-consultation-rare-disease-day-podcast-blog/) - For this week’s email, we share some initial intelligence on the inter-service consultation on the EU Pharma Package as well as our latest podcast and blog on Rare Disease Day. Initial intel on the inter-service consultation on Pharma Package The Commission’s inter-service consultation (ISC) on the Pharma Package ended on 14 February. We understand that - [OMP WG | Digital Health WG | RWE Position Paper | RD event at EU Parl](https://www.eucope.org/membersonly/omp-wg-digital-health-wg-rwe-position-paper-rd-event-at-eu-parl/) - In today’s email, we share the details for our upcoming OMP and Digital Health Working Group Meetings, the release of our latest position paper on RWE and an invite to an upcoming Rare Disease Day event hosted at the European Parliament. OMP Working Group Meeting (4 April: 11:00 – 15:00 CET, hybrid) We would to - [Members Meeting Slides | Virtual Town Hall | EHDS draft | Public Health sub-committee](https://www.eucope.org/membersonly/members-meeting-slides-virtual-town-hall-ehds-draft-public-health-sub-committee/) - We would like to sincerely thank everyone for their participation and engagement during yesterday’s first quarterly Members’ Meeting of 2023. In this email, we provide the presentation from yesterday’s meeting, an invite to our upcoming virtual Town Hall on 7 March, a timely update on the draft report of the European Health Data Space (EHDS), - [P&R WG | Regulatory Intel | New Blog | World EPA Congress](https://www.eucope.org/membersonly/pr-wg-regulatory-intel-new-blog-world-epa-congress/) - Dear Members, In this email, we share an invitation to the next P&R/Market Access Working Group, an update on Regulatory insights related to the EU Pharma Package proposal, a link to our latest blog for World Cancer Day and an invite to the upcoming World EPA Congress, with a special 50% discount for EUCOPE members. - [GPL/OMP Intel | SoHO | EU HTA Podcast | EU Rare Disease Summit](https://www.eucope.org/membersonly/gpl-omp-intel-soho-eu-hta-podcast-eu-rare-disease-summit/) - In this week’s email, we share some intelligence regarding the revision of the general pharmaceutical legislation and OMP Regulation, our comments on the draft report of the SoHO proposal, our latest podcast on the new EU HTA Procedure and an invitation to the upcoming Europe Rare Disease Summit, with a 50% discount for EUCOPE Members. - [Data Act | Regulatory WG | MDR/IVDR | C> Summit](https://www.eucope.org/membersonly/data-act-regulatory-wg-mdr-ivdr-cgt-summit/) - Dear Members, In this email, we provide announce our latest action related to the Data Act, an invitation to the upcoming Regulatory Working Group meeting and the Economist’s Cell and Gene Therapy Summit plus a call for any members wishing to participate in EUCOPE’s work on medical devices and/or in vitro diagnostic medical devices. EUCOPE - [MDR | Public Health Sub-Committee | Life Sciences College | EUCOPE Members Meeting](https://www.eucope.org/membersonly/mdr-public-health-sub-committee-life-sciences-college-eucope-members-meeting/) - Dear Members, In this week’s email, we’d like to share some recent updates regarding the Medical Devices Regulation (MDR), the new public health sub-committee, an invitation to the Life Sciences College and a reminder about our upcoming Members’ Meeting in February. European Commission to adopt extension to Medical Devices Regulation Good news for medical devices - [Launch Conditionality | End of Year Review | EIC-EMA Day](https://www.eucope.org/membersonly/launch-conditionality-end-of-year-review-eic-ema-day/) - For the winter solstice and last Members Mail of 2022, we would like to share two new podcasts, a blog piece on Launch Conditionality and an invite to the EICC-EMA Info Day in January 2023. Sounds of Science Episode 10 - Launch Conditionality: The impact on small and mid-sized companies Several incentives are being considered - [EPSCO Updates | Swedish Presidency Priorities](https://www.eucope.org/membersonly/epsco-updates-swedish-presidency-priorities/) - We include two updates – Pharmaceutical Package and Medical Devices Regulation - that were discussed at the recent EPSCO meeting as well as the set of priorities published by the incoming Swedish EU Council Presidency. Pharmaceutical Package update in Employment, Social Policy, Health and Consumer Affairs Council configuration (EPSCO) On 9 December, the EPSCO met - [Rare Disease Moonshot | HERA Report | Rare Disease Summit](https://www.eucope.org/membersonly/rare-disease-moonshot-hera-report-rare-disease-summit/) - Launch of Rare Disease Moonshot Initiative A new initiative to boost research and development into rare and paediatric diseases was launched today at the European Health Summit. The ‘Rare Disease Moonshot’ is a commitment and collaboration between seven organisations – one of which is EUCOPE - to break down the barriers to finding new treatments and cures - [MDR Changes | Kyriakides on GPL | WSJ Request](https://www.eucope.org/membersonly/mdr-changes-kyriakides-on-gpl-wsj-request/) - The European Commission to propose legal changes to the Medical Devices Regulation to prevent medical devices crisis Important news on medical devices. Health Commissioner Stella Kyriakides told the European Parliament that the European Commission will propose a set of options – including legislative – to prevent dangerous shortfalls in medical devices due to struggles to - [Cancer Screening Update | P&R Working Group Agenda](https://www.eucope.org/membersonly/cancer-screening-update-pr-working-group-agenda/) - The Council has agreed on the text for the updated Recommendation on Cancer Screening As we have informed you previously, the European Commission’s Europe’s Beating Cancer plan proposed to update the 2003 Council Recommendation on cancer screening, to reflect the latest technological advances and possibly extend the recommendations to cover new areas of cancer. To - [OMP WG Slides | Together4RD Launch | PinkSheet Feature](https://www.eucope.org/membersonly/omp-wg-slides-together4rd-launch-pinksheet-feature/) - Slides: Orphan Medicinal Products (OMP) Working Group (3 November) We would like to share the presentation of the latest working group on orphan medicinal products and some next steps for engagement. The morning session served as an opportunity to share the latest intelligence on the review of the OMP legislation. We had an overview of - [Structured Dialogue's Staff Working Document](https://www.eucope.org/membersonly/structured-dialogues-staff-working-document/) - Staff Working Document on the vulnerabilities of the global supply chains of medicines The European Commission published its Staff Working Document (SWD) on the vulnerabilities of the global supply chains of medicines (see below). The SWD was a required output from the Structured Dialogue, to which EUCOPE participated in 2021 and summarizes the findings from - [P&R/Market Access WG Slides | EU HTA Concerns | DIA/EUCOPE Workshop](https://www.eucope.org/membersonly/pr-market-access-wg-slides-eu-hta-concerns-dia-eucope-workshop/) - For this week’s email, we share our latest joint statement over the EU HTA Regulation, the slides from the last P&R/Market Access Working Group and an invite to the DIA/EUCOPE workshop on Innovative Therapies in Europe. EUCOPE/EFPIA Joint Statement – Concerns over the implementation of the EU HTA Regulation This is a critical moment for - [Career Centre - Job Posting Template](https://www.eucope.org/membersonly/career-centre-job-posting-template/) - Please click on the link below to access the Job Posting Template for the EUCOPE Career Centre. Career Centre - Job Posting Template After filling out the form, kindly submit to office@eucope.org for approval and posting. - [Members Meeting Slides | Update on Timelines | ATMPs Podcast | Event Recaps](https://www.eucope.org/membersonly/members-meeting-slides-update-on-timelines-atmps-podcast-event-recaps/) - Dear Members, Thank you very much for your lively and concentrated participation during yesterday’s quarterly Members Meeting. We hope you enjoyed the opportunity to reconnect and tackle some of the most pressing regulatory and policy issues in Europe. For this email, you will find the full slidedeck from yesterday’s meeting, an update on timelines for - [OMP WG Meeting | EUCOPE Members Meeting | Career Centre](https://www.eucope.org/membersonly/omp-wg-meeting-eucope-members-meeting-career-centre/) - Dear Members, For this week’s email, we would like to share the invite to the next OMP Working Group meeting, a reminder about next week’s EUCOPE Members Meeting and announce the launch of our new Career Centre for Members. EUCOPE Orphan Medicinal Products (OMP) Working Group (3 November: 11:00 – 15:00 CET) The next meeting of - [EMA Workshop Recording | EHDS Blog | Calendar of Events](https://www.eucope.org/membersonly/ema-workshop-recording-ehds-blog-calendar-of-events/) - We don’t many updates this week besides some recordings from an EMA multi-stakeholder workshop and our recent EHDS blogpost in BIO.news. If you haven’t seen on LinkedIn or our newsletter, we would also like to announce the newest member of the EUCOPE team, Dr. Axel Korth. He will be acting as our Senior Legal & - [EC Letter on GPL & OMP | EMA Statement on biosimilars | Ukraine Impact | EHDS Podcast](https://www.eucope.org/membersonly/ec-letter-on-gpl-omp-ema-statement-on-biosimilars-ukraine-impact-ehds-podcast/) - This week, we share our letter to the European Commission on the General Pharmaceutical Legislation and OMP Regulation, the EMA/HMA joint statement on biosimilars, a request for feedback on the impact of Ukraine-Russia war on medicinal products and our latest podcast on the European Health Data Space (EHDS). EUCOPE letter on the revision of the - [The Council of the EU has agreed on a mandate on the proposal for a Regulation on HTA](https://www.eucope.org/membersonly/the-council-of-the-eu-has-agreed-on-a-mandate-on-the-proposal-for-a-regulation-on-hta/) - Dear Members, On 24 March, the Council of the European Union has agreed on a mandate to enter into trilogue negotiations with the other EU institutions on the European Commission's proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU (2018/0018 (COD)). The Council position on the proposed legislation is based on a - [Invitation to Pricing & Reimbursement/Market Access Working Group Meeting, 3 March 2021](https://www.eucope.org/membersonly/invitation-to-pricing-reimbursement-market-access-working-group-meeting-3-march-2021/) - Dear Members, In the following, we would like to share updates on the pilot project 'Market Launch Intentions of Centrally Authorised Products' and the so called 'Oslo Medicines Initiative' that we previously reported on and have selected as topics for the upcoming Pricing & Reimbursement/Market Access Working Group meeting to be held via videoconference on - [EUCOPE White Paper on Artificial Intelligence / Recording of EUCOPE Event on Digital Health](https://www.eucope.org/membersonly/eucope-white-paper-on-artificial-intelligence-recording-of-eucope-event-on-digital-health/) - Dear Members, With this , we would like to share with you the EUCOPE White Paper on Artificial Intelligence, as well as the video recording of the EUCOPE event on Digital Health that took place on 27 January. 1. EUCOPE White Paper on Artificial Intelligence On the last week of January, EUCOPE published its White - [The European Commission releases 'Europe's Beating Cancer Plan'](https://www.eucope.org/membersonly/the-european-commission-releases-europes-beating-cancer-plan/) - Dear Members, Today the European Commission released "Europe's Beating Cancer Plan", which represents the largest EU initiative on cancer since the 1990s and a key pillar of the European Health Union. With this email we would like to follow-up on our early look at the plan from a few weeks ago with a more detailed - [Publication of the inception impact assessment on HERA](https://www.eucope.org/membersonly/publication-of-the-inception-impact-assessment-on-hera/) - Dear Members, With this email, we would like to inform you of the inception impact assessment on the European Health Emergency Preparedness and Response Authority (HERA) that the European Commission published on 27 January. Public consultation on inception impact assessment on HERA This is the fourth proposal launched by the Commission in the context of - [Members Meeting, 23 February - EUCOPE Paper on Innovative Payment Models for ATMPs](https://www.eucope.org/membersonly/members-meeting-23-february-eucope-paper-on-innovative-payment-models-for-atmps/) - Dear Members, Please find in the following the invitation to the next Members Meeting and information on the EUCOPE Position Paper on Innovative Payment Models for ATMPs 1. EUCOPE Members Meeting, 23 February, 11:00 a.m. – 2:00 p.m. CET Please find attached the agenda for the next Members Meeting, which will take place on 22 - [EUCOPE Members and General Meeting on 14 October 2020](https://www.eucope.org/membersonly/eucope-members-and-general-meeting-on-14-october-2020/) - Dear Members, Given the most recent travel restrictions to and from Belgium, we would like to inform you that the EUCOPE Board has decided to have the upcoming General and Members Meetings on 14 October in a virtual format only and not in the originally planned hybrid form. We hope that this limitation to remote - [The European Commission seeks feedback on its Intellectual Property Action Plan](https://www.eucope.org/membersonly/the-european-commission-seeks-feedback-on-its-intellectual-property-action-plan/) - Dear Members, On 10 July the European Commission has published a Roadmap on the forthcoming Intellectual Property Action Plan (here below). The IP action plan is not sector specific. However, it mentions supplementary protection certificates (SPCs) at two points. Altogether the document sets out the Commission’s general vision on the role of IP in the - [European Commission's Evaluation on Paediatric & Orphan drugs Regulations](https://www.eucope.org/membersonly/european-commissions-evaluation-on-paediatric-orphan-drugs-regulations/) - Dear Members, With this email, we would like to share with you the European Commission’s Staff Working Document (SWD) on Orphan and Paediatric Medicinal Products Regulations published on 11 August. The document is made up of one main text (here below) and 5 extra papers of annexes available at this link. An executive summary is - [EMA’s Transparency in Relation to COVID-19 Products - Public Consultation on EMA/HMA Joint Strategy](https://www.eucope.org/membersonly/emas-transparency-in-relation-to-covid-19-products-public-consultation-on-ema-hma-joint-strategy/) - Dear Members, Please find in the following information on EMA’s new transparency policy in relation to COVID-19 products as well as on a public consultation on the EMA/HMA’s joint strategy. We also want to remind you of the pilot project on market launch intentions. EMA’s Transparency in Relation to COVID-19 Products The EMA has announced - [EU Clinical Trials Regulation to apply from December 2021 - CTIS Newsletter](https://www.eucope.org/membersonly/eu-clinical-trials-regulation-to-apply-from-december-2021-ctis-newsletter/) - Dear Members, With this email, we would like to share some important information regarding the new date of implementation of the Clinical Trials Regulation and the status of the Clinical Trials Information System. Clinical Trials Regulation to apply from December 2021 The European Medicines Agency (EMA) Board announced earlier this month that the centralised EU - [COM Survey on Market Launch of Centrally Authorised Products](https://www.eucope.org/membersonly/com-survey-on-market-launch-of-centrally-authorised-products/) - Dear Members, As we have previously reported, the European Commission considers measures to address “delayed or staggered market launch” of new medicines across the EU. Based on discussions of the ad-hoc Working Group of National Competent Authorities, the Commission now seeks to launch a pilot project in Q3 of 2020, where companies voluntarily and confidentially - [Survey on the Pharmaceutical Strategy - for members input by 20 July](https://www.eucope.org/membersonly/survey-on-the-pharmaceutical-strategy-for-members-input-by-20-july/) - Dear Members, With this email we would like to share the open consultation ‘’Survey on the Pharmaceutical Strategy’’ launched today by the European Commission as part of the process of stakeholder consultation started earlier in June with the publication of the Pharmaceutical Strategy Roadmap. The Strategy is expected for publication in Q4 2020. The open - [Germany, France, Italy and the Netherlands form an "Inclusive Vaccine Alliance" - EU strategy for joint negotiations on a vaccine](https://www.eucope.org/membersonly/germany-france-italy-and-the-netherlands-form-an-inclusive-vaccine-alliance-eu-strategy-for-joint-negotiations-on-a-vaccine/) - Dear Members, Last week, Germany, France, Italy and the Netherlands formed an Inclusive Vaccine Alliance in order to negotiate with the pharmaceutical industry to ensure that a future COVID-19 vaccine becomes accessible, available and affordable for the EU and beyond. According to the Memorandum of Understanding, the rationale for the Alliance is to make the - [EMA consultation on the impact of EU data protection legislation on the secondary use of health data](https://www.eucope.org/membersonly/ema-consultation-on-the-impact-of-eu-data-protection-legislation-on-the-secondary-use-of-health-data/) - Dear Members, The European Medicines Agency (EMA) has published a Discussion Paper for Medicines Developers, Data Providers, Research-Performing and Research-Supporting Infrastructures (attached) and is currently gathering input from industry. This consultation serves the purpose of preparing a guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the - [EU Pharmaceutical Strategy roadmap published | Next meeting of advocacy working group - 16 June](https://www.eucope.org/membersonly/eu-pharmaceutical-strategy-roadmap-published-next-meeting-of-advocacy-working-group-16-june/) - Dear Members We would like to share the European Pharmaceutical Strategy Roadmap the European Commission published today (here attached) and the next date of the EUCOPE Advocacy Working Group on 16 June. The roadmap describes the issues the Pharmaceutical Strategy aims to tackle and by what means and the next steps in the consultation process. - [EU Recovery Plan and EU4Health Programme unveiled](https://www.eucope.org/membersonly/eu-recovery-plan-and-eu4health-programme-unveiled/) - Dear Members, With this email, we would like to provide you with an update on the newly proposed budgetary measures in light of the COVID-19 crisis and their implications on health. EU Recovery Plan On 27 May, the European Commission presented the EU Recovery Plan with the objective to relaunch the economy and lay the - [P&R Working Group Conference Call, 18 June - Gene & Cell Therapy Working Group - Nordic Joint Negotiations](https://www.eucope.org/membersonly/pr-working-group-conference-call-18-june-gene-cell-therapy-working-group-nordic-joint-negotiations/) - Dear Members, We would like to invite you to the next virtual meeting of the EUCOPE Pricing & Reimbursement/Market Access Working Group which will take place on 18 June, 11 am – 1 pm. We will, inter alia, discuss the impact of the current pandemic on HTA processes across Europe, the German method paper of - [EUCOPE OMP WG Meeting, 10 June 2020 | The IRDiRC Orphan Drug Development Guidebook](https://www.eucope.org/membersonly/eucope-omp-wg-meeting-10-june-2020-the-irdirc-orphan-drug-development-guidebook/) - Dear Members, With this email, we would like to share with you some information with regards to the next OMP Working Group meeting and the recent publication of the IRDiRC Orphan Drug Development Guidebook. Orphan Medicinal Products (OMP) Working Group meeting – 10 June 2020, teleconference The next OMP Working Group meeting will take place - [COVID-19 - Questionnaire on the impact of the pandemic - Accelerated procedures for COVID-19 treatments and vaccines](https://www.eucope.org/membersonly/covid-19-questionnaire-on-the-impact-of-the-pandemic-accelerated-procedures-for-covid-19-treatments-and-vaccines/) - Dear Members, As you know, since the beginning of the COVID-19 crisis in Europe we have weekly conference calls with the European Commissioner for Health and the Commissioner for the Internal Market as well as DG SANTE and the EMA. We have shared with you in previous emails lists of questions the Commission sent to - [EU Joint Procurements for Investigational and Essential ICU Therapeutics](https://www.eucope.org/membersonly/eu-joint-procurements-for-investigational-and-essential-icu-therapeutics/) - Dear Members We would like to share some ongoing developments on EU Joint Procurements and remind you of the upcoming EUCOPE and DIA ATMPs online workshop of 27-28 May, that EUCOPE members can access at a discounted rate. 1.EU Joint procurements for investigational and essential ICU therapeutics As you know the European Commission has set - [EUCOPE Members and General Meeting in June to be postponed to October](https://www.eucope.org/membersonly/eucope-members-and-general-meeting-in-june-to-be-postponed-to-october/) - Dear Members, I hope you and your families are all keeping well in these difficult circumstances. Given the many restrictions we are all currently facing and the uncertainties when and to what degree they will be loosened, we have decided not to schedule any face-to-face meetings at least until the end of June. While we - [Q&A on Regulatory Flexibility / SME Connect Webinar / EUCOPE-DIA Joint Workshop](https://www.eucope.org/membersonly/qa-on-regulatory-flexibility-sme-connect-webinar-eucope-dia-joint-workshop/) - Dear Members We would like to inform you of the latest update to the EMA Q&A document on Regulatory Flexibility during COVID-19, a webinar organised by SME Connect on the role of small & medium companies in fighting the pandemic and the 2nd EUCOPE-DIA Joint Workshop on Gene & Cell Therapies. EMA Q&A Document on - [COVID-19: EU Executive Steering Group on Shortages of Medicines - 15 April TC](https://www.eucope.org/membersonly/covid-19-eu-executive-steering-group-on-shortages-of-medicines-15-april-tc/) - Dear Members, We would like to share with you a summary of yesterday call of the EU Executive Steering Group on shortages of medicines caused by the COVID-19 pandemic, EUCOPE and other industry stakeholders took part in: The third revision of the Guidance on clinical trial management during the COVID-19 pandemic will be released in - [European Commission to propose postponement of MDR Implementation](https://www.eucope.org/membersonly/european-commission-to-propose-postponement-of-mdr-implementation/) - Dear Members, The European Commission just announced that their services are now working on a proposal to postpone the implementation of the Medical Devices Regulation (MDR – 2017/745) by one year. DG SANTE says: “As such, today (25 March 2020), and with patient health and safety as a guiding principle, the Commission announced that work - [EC eHealth Stakeholder Group - EUCOPE Regulatory Working Group Meeting Slide deck](https://www.eucope.org/membersonly/ec-ehealth-stakeholder-group-eucope-regulatory-working-group-meeting-slide-deck/) - Dear Members, With this email, we would like to inform you of the successful application of EUCOPE to the European Commission eHealth Stakeholder Group and share with you the slide deck that was presented at our Regulatory Working Group meeting this week. EC eHealth Stakeholder Group – EUCOPE in It is our pleasure to let - [Slide Deck Members Meeting, 26 February](https://www.eucope.org/membersonly/slide-deck-members-meeting-26-february/) - Dear Members, Please find attached the slides presented at the EUCOPE Members Meeting last week. The slide deck contains amongst others the European Commission’s presentation on the work of the Repurposing Observatory Group of the EMA as well as the slides on the OECD’s report on performance-based managed entry agreements. The deck also includes an - [EUCOPE Members Meeting, 26 February, Brussels - European Joint Programme on Rare Diseases](https://www.eucope.org/membersonly/eucope-members-meeting-26-february-brussels-european-joint-programme-on-rare-diseases/) - Dear Members, Please find in the following the invitation to the next Members Meeting and an invitation to a Networking Event in the context of the European Joint Programme on Rare Diseases. EUCOPE Members Meeting, 26 February, Brussels Please find attached the agenda for the next Members Meeting, which will take place on 26 February - [EUCOPE OMP Working Group Meeting 5 March - Draft Agenda | Europe’s Beating Cancer Plan Consultation Roadmap](https://www.eucope.org/membersonly/eucope-omp-working-group-meeting-5-march-draft-agenda-europes-beating-cancer-plan-consultation-roadmap/) - Dear Members With this email we would like to share with you the draft agenda of the OMP meeting of 5 March and the recent European Commission Europe’s Beating Cancer consultation. OMP Working Group Meeting Agenda Attached you find a draft agenda for our meeting on 5 March from 11:00 to 16:00. An updated version - [EU Court of Justice on Third Parties' Access to Clinical Trials Data](https://www.eucope.org/membersonly/eu-court-of-justice-on-third-parties-access-to-clinical-trials-data/) - On the 21 January, the Court of Justice of the European Union published its decision on three cases concerning third parties’ rights of access to documents contained in the marketing authorisation dossier. The Court, in particular, stated that the Clinical Study Reports (CSR) to which third parties had requested access, were not covered by a - [Regulatory/Medical Device/Pharmacovigilance Working Group - Priorities 2020 and Agenda Meeting 12 February](https://www.eucope.org/membersonly/regulatory-medical-device-pharmacovigilance-working-group-priorities-2020-and-agenda-meeting-12-february/) - Dear Members We would like to share with you some information with regards to our Regulatory / Medical Device / Pharmacovigilance Working Group. The next meeting is scheduled for 12 February in Brussels. The agenda for this meeting reflects the priorities of this working group for 2020 which are: 1. Research & Development / Regulatory - [EUCOPE P&R Working Group Slide Deck - EC summary of Biosimilar Workshop](https://www.eucope.org/membersonly/eucope-pr-working-group-slide-deck-ec-summary-of-biosimilar-workshop/) - Dear Members, With this email, we would like to share with you the slide deck presented at the last meeting of EUCOPE’s Pricing & Reimbursement / Market Access Working Group which took place in Brussels on 21 November 2019. This slide deck contains, inter alia, presentations on: The EURIPID 2nd Dialogue Stakeholder Meeting; Latest developments - [Industry stakeholder meetings at the EMA: Latest Updates](https://www.eucope.org/membersonly/1251/) - Dear Members, We would like to provide you with a brief summary of the latest Industry stakeholder meetings at the EMA, namely: EMA Regulatory Science Strategy (RSS) to 2025 post-public consultation stakeholders workshop – human medicines As informed previously the European Medicines Agency was holding a multi-stakeholder workshop on its Regulatory Science to 2025 strategy - [Compounding in the Netherlands - Regulatory Working Group Slides](https://www.eucope.org/membersonly/compounding-in-the-netherlands-regulatory-working-group-slides/) - Dear Members, We would like to provide you with some updates on the recent developments on compounding in the Netherlands and the slide deck presented at our latest Regulatory, Medical Devices and Pharmacovigilance Working Group. Compounding and IP in the Netherlands During the latest EUCOPE Off-Label Use Task Force meeting, on 4 November, Peter Bertens - [European Commission publishes options for a new EMA fee structure](https://www.eucope.org/membersonly/european-commission-publishes-options-for-a-new-ema-fee-structure/) - Dear Members, The European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA) together with an Inception Impact Assessment (which can be downloaded here). The latter outlines three different options on how the EMA fee system could be changed. A respective legislative proposal has been announced for - [Medical Devices & IVD Regulations: Latest MDCG Meeting](https://www.eucope.org/membersonly/medical-devices-ivd-regulations-latest-mdcg-meeting/) - Dear Members, With this email, we would like to share with you the latest updates from the implementation of the Medical Devices Regulation (2017/745) and In Vitro Diagnostics Devices Regulation (2017/746). Medical Devices & IVD Regulations: Meeting of the Medical Devices Coordination Group (MDCG) On 30 September, the European Commission invited stakeholders to join the - [World Orphan Drug Congress: November, Barcelona | Legal Working Group meeting: 30 September, Geneva](https://www.eucope.org/membersonly/world-orphan-drug-congress-november-barcelona-legal-working-group-meeting-30-september-geneva/) - Dear Members, We would like to inform you about two upcoming events: 1. World Orphan Drug Congress Europe – 12-14 November, Barcelona From 12 to 14 November, EUCOPE will participate to the 10th World Orphan Drug Congress taking place in Barcelona. This event will gather representatives of regulatory and payer agencies, of HTA bodies, patient - [OMP Working Group meeting: 9 October | Revision of the Czech Public Health Insurance Act](https://www.eucope.org/membersonly/omp-working-group-meeting-9-october-revision-of-the-czech-public-health-insurance-act/) - Dear Members, We would like to share with you some information with regards to the next OMP Working Group meeting and some legislative developments in Czech Republic. 1. Orphan Medicinal Products (OMP) Working Group meeting – 9 October, Brussels The next OMP Working Group meeting will take place on 9 October (11.00-16.00 CET), at our - [Members Meeting 16 October - Agenda / P&R 10 September - Slides](https://www.eucope.org/membersonly/members-meeting-16-october-agenda-pr-10-september-slides/) - Dear Members, Please find in the following the invitation to the next Members Meeting, a report of a meeting with the Maltese Health Minister as well as a short follow-up on the last Pricing & Reimbursement/Market Access Working Group Meeting. I. EUCOPE Members Meeting, 16 October, Brussels Please find attached the agenda for the next - [EC Conference on medicines for rare diseases and children / ERNs / RARE2030](https://www.eucope.org/membersonly/1168/) - Dear Members, We would like to provide you with an update on the recent developments and ongoing projects related to Orphan Medicinal Products (OMP), including the summary of the EU Commission conference on medicines for rare diseases and children, European Reference Networks (ERNs) and RARE2030. EU Commission conference on medicines for rare diseases and children: - [P&R/Market Access WG Meeting, 10/09 - Italy: New Decree on P&R Procedures - EUnetHTA: Public Consultation on Clinical Effectiveness](https://www.eucope.org/membersonly/pr-market-access-wg-meeting-10-09-italy-new-decree-on-pr-procedures-eunethta-public-consultation-on-clinical-effectiveness/) - Dear Members, We would like to remind you of the upcoming meeting of the Pricing & Reimbursement/Market Access Working Group which takes place on 10 September, 11 am – 4 pm at our premises in rue Marie de Bourgogne 58, Brussels. At this meeting we will, inter alia, take a look at reimbursement procedures in - [EC eHealth Stakeholder Group - Expression of Interests](https://www.eucope.org/membersonly/ec-ehealth-stakeholder-group-expression-of-interests/) - Dear Members, We would like to share with you the call for expression of interests for the European Commission’s eHealth Stakeholder Group. Expression of interests for the European Commission’s eHealth Stakeholder Group The European Commission recently called on stakeholders to apply for the selection of members of its eHealth Stakeholder Group, for the new mandate - [EUCOPE Legal Working Group Meeting: 30 Sept, Geneva - EUCOPE Post-EU Elections Workshop: 11 Sept, Brussels](https://www.eucope.org/membersonly/eucope-legal-working-group-meeting-30-sept-geneva-eucope-post-eu-elections-workshop-11-sept-brussels/) - Dear Members, Please find in the following details of the next EUCOPE Legal Working Group Meeting and a EUCOPE Post-EU Elections Workshop as well as a “Policy Passport for MEPs”. EUCOPE Legal Working Group We would like to invite you to the next meeting of the EUCOPE Legal Working Group. The meeting takes place on - [Performance-driven payments & ATMPs Market Access - Discount for EUCOPE Members](https://www.eucope.org/membersonly/performance-driven-payments-atmps-market-access-discount-for-eucope-members/) - Dear Members, we would like to draw your attention to the following two events organized by Forum in Germany: Performance-Driven Payments in Europe on 18 September 2019 in Berlin Payment of high-priced drugs in the UK, BeNeLuxAI, Italy and Germany The German draft drug law GSAV foresees registries for orphan drugs; first performance-driven payment contracts - [P&R/Market Access Working Group Meeting, 10 September, Brussels - Euripid: Stakeholder Dialogue Platform](https://www.eucope.org/membersonly/pr-market-access-working-group-meeting-10-september-brussels-euripid-stakeholder-dialogue-platform/) - Dear Members, Please find in the following the details for the next meeting of the EUCOPE Pricing & Reimbursement/Market Access Working Group as well as information on the EURIPID Stakeholder Dialogue Platform. EUCOPE Pricing & Reimbursement/Market Access Working Group, 10 September, Brussels The next P&R/Market Access Working Group will take place on 10 September, 11 - [Pricing & Reimbursement / Market Access Slides - Germany: GSAV Bill - TRUST4D Paper Finalised](https://www.eucope.org/membersonly/pricing-reimbursement-market-access-slides-germany-gsav-bill-trust4d-paper-finalised/) - Dear Members, We would like to share with you the slide deck presented at the recent Pricing & Reimbursement / Market Access Working Group Meeting; an update on the GSA-V bill in Germany, as well as the paper from the TRUST4RD initiative. Pricing & Reimbursement / Market Access Working Group Meeting, 4 June, Presentations Please - [Reminder: Members + General Meeting on 25 June | Workshop "Innovative Contracting in Germany" on 24 June](https://www.eucope.org/membersonly/reminder-members-general-meeting-on-25-june-workshop-innovative-contracting-in-germany-on-24-june/) - Dear Members, We would like to remind you that the next EUCOPE Members Meeting and EUCOPE General Meeting will take place on 25 June 2019 at our offices in rue Marie de Bourgogne 58, 2nd floor, 1000 Brussels/Belgium and will be preceded by a workshop on “Innovative Contracting in Germany” on 24 June. Members Meeting - [OMP Working Group meeting slides (15 May) | Rare 2030 Project | RDR Initiative](https://www.eucope.org/membersonly/omp-working-group-meeting-slides-15-may-rare-2030-project-rdr-initiative/) - Dear Members, We would like to share with you the highlights and slides of the last Orphan Medicinal Products (OMP) Working Group meeting of 15 May as well as to provide a brief update on the Rare 2030 Project led by EURORDIS, and the Rare Diseases Research Challenges Initiative. OMP Working Group meeting – highlights - [UK Recent News: MHRA Business Plan - Accelerated Access - Brexit - New Costing Tool](https://www.eucope.org/membersonly/uk-recent-news-mhra-business-plan-accelerated-access-brexit-new-costing-tool/) - MHRA Publishes Business Plan for 2019-20 The Medicines and Healthcare Products Regulatory Agency (MHRA) has published its business plan for next year, explaining its main goals and objectives for 2019-20. The Agency‘s key actions will focus on: Deploying existing regulatory products to support innovation further; Engaging more intelligently with patients and the sector to increase - [EUCOPE Members Meeting & General Meeting - 25 June 2019](https://www.eucope.org/membersonly/eucope-members-meeting-general-meeting-25-june-2019/) - Dear Members, We would like to invite you to attend the next EUCOPE Members Meeting and EUCOPE General Meeting which take place on 25 June 2019 at our offices at rue Marie de Bourgogne 58, 2nd floor, 1000 Brussels/Belgium. Members Meeting and General Meeting The Members Meeting will take place between 11am - 4pm. Please - [EUCOPE Competition Law Compliance Policy](https://www.eucope.org/membersonly/eucope-competition-law-compliance-policy/) - Dear Members, A quick note to inform you that EUCOPE has updated its Competition Law Compliance Policy. You can find it here. For any further question, please contact Dr Oliver Sude, EUCOPE General Counsel. - [Legal opinion on binding nature of joint HTA to be published in May | EUCOPE Workshop “Innovative Contracting in Germany”, 24 June in Brussels](https://www.eucope.org/membersonly/legal-opinion-on-binding-nature-of-joint-hta-to-be-published-in-may-eucope-workshop-innovative-contracting-in-germany-24-june-in-brussels/) - Dear Members, Please find in the following an update on the EU HTA coordination proposal as well as an invitation to our yearly workshop “Innovative Contracting in Germany” which takes place on 24 June in Brussels. 1. HTA-Proposal: Legal Opinion on Binding Nature of Joint Clinical Assessments The controversial legislative proposal for a Regulation on - [MAP BioPharma Report on access to OMPs in the UK | EUCOPE OMP WG meeting, 15 May](https://www.eucope.org/membersonly/map-biopharma-report-on-access-to-omps-in-the-uk-eucope-omp-wg-meeting-15-may/) - Dear Members, We would like to share with you a recently-published MAP Biopharma report on access to OMPs in the UK. We would also like remind you of the next OMP Working Group meeting. 1. MAP BioPharma report on access to OMPs in the UK Further to a review of the data and policy environment - [Medical Devices Coordination Group Subgroups & Task Forces Meeting Reports | Public Consultation on Intentionally added Microplastics](https://www.eucope.org/membersonly/medical-devices-coordination-group-subgroups-task-forces-meeting-reports-public-consultation-on-intentionally-added-microplastics/) - Dear Members, We would like to share with you some updates from the Working Groups and Task Forces of the Medical Devices Coordination Group (MDCG), and on a public consultation on the use of micro-plastics and polymer in medical devices and in vitro diagnostics. 1. MDCG Working Groups and Task Forces As you may know, - [Report on the Development of Pharmaceutical Prices in Europe - Spain: Ongoing Review of Pricing Criteria - Study on “Funding OMPs”](https://www.eucope.org/membersonly/report-on-the-development-of-pharmaceutical-prices-in-europe-spain-ongoing-review-of-pricing-criteria-study-on-funding-omps/) - Dear Members, Please find below information on a new report on the development of pharmaceutical prices in Europe published by the Swedish Dental and Pharmaceutical Benefits Agency, plans of the Spanish government to set up new pricing rules and the publication of an analysis of the impact of the OMP Regulation on health systems by - [EUCOPE Regulatory / Medical Devices Working Group - Agenda](https://www.eucope.org/membersonly/eucope-regulatory-medical-devices-working-group-agenda/) - Dear Members, Please find here enclosed the agenda of our coming Regulatory and Medical Devices Working Group meeting. We will, inter alia, discuss: Brexit implications; Registries; Medical Devices; R&D EMA focus groups. Agenda: Here. When? 02 May 2019 - 11.00 to 16.00hrs Where? EUCOPE, Rue Marie de Bourgogne, 58 - 1000 Brussels, Belgium Register: Please - [Brexit No Deal Preparations I EMA Consultation for Theft of Medicinal Products](https://www.eucope.org/membersonly/brexit-no-deal-preparations-i-ema-consultation-for-theft-of-medicinal-products/) - Dear Members, Please find in the following the latest information on Brexit “no deal” preparations as well as the recent EMA consultation on the theft of medicinal product. Brexit “no deal” preparations – shortage catalogue If the UK will leave the EU without a deal on 12 April and EU law will cease to apply - [EUCOPE survey on member companies’ footprint in the EU | Presentation of the last Members' Meeting](https://www.eucope.org/membersonly/eucope-survey-on-member-companies-footprint-in-the-eu-presentation-of-the-last-members-meeting/) - Dear Members, Please find in the following about information about the EUCOPE survey on member companies’ footprint in the EU and the slide deck of the last Members’ Meeting which took place on 26 February 2019. EUCOPE survey on member companies' footprint in the EU – deadline 15 April 2019 In the context of the - [MDR/IVDR Implementation Update - MDCG Meeting | P&R Meeting Slides](https://www.eucope.org/membersonly/mdr-ivdr-implementation-update-mdcg-meeting-pr-meeting-slides/) - Dear Members, We would like to share with you the latest information on the implementation of the Medical Devices Regulation (MDR) and in-vitro Diagnostics Regulation (IVDR) provided by the European Commission at the recent meeting of the Medical Devices Coordination Group (MDCG). You will also find the slides presented at the latest EUCOPE Pricing & - [OMP WG meeting materials | Rare Diseases Challenges Workshop | Agreement on proposed Regulation for an SPC manufacturing waiver and stockpilling](https://www.eucope.org/membersonly/omp-wg-meeting-materials-6-february-rare-diseases-challenges-workshop-report-12-february-interinstitutional-agreement-on-proposed-regulation-for-an-spc-manufacturing-waiver-and-stockpilling/) - Dear Members, We would like to share with you the materials pertaining to the OMP Working Group meeting of 6 February 2019 as well as information about the Rare Diseases Challenges Workshop held on 12 February. Finally, you will find an update on the inter-institutional trilogue negotiations with regards to the EC Proposal for an - [Reporting obligations falsified medicinal products I HMA/EMA on availability of authorised medicines I EMA platform on R&D I Brexit](https://www.eucope.org/membersonly/reporting-obligations-falsified-medicinal-products-i-hma-ema-on-availability-of-authorised-medicines-i-ema-platform-on-rd-i-brexit/) - Dear Members, We would like to provide you with the latest EMA information: 1. Delegated Regulation on safety features – reporting obligations – 9 February 2019 As you are aware, the Commission Delegated Regulation (EU) 2016/161 entered into application on 9 February 2019 and supplements the EU Directive 2011/62/EU ('Falsified medicines directive’), with the aim - [Germany: Government agrees on new pharmaceutical bill - Reminder: Members Meeting on 26 February in Brussels](https://www.eucope.org/membersonly/germany-government-agrees-on-new-pharmaceutical-bill-reminder-members-meeting-on-26-february-in-brussels/) - Dear Members, On 30 January, the German government has agreed on a draft Act for more safety in the supply of pharmaceuticals (Gesetz für mehr Sicherheit in der Arzneimittelversorgung – in the following: “GSAV”). Although the wording of the original bill has been amended since it was released by the Ministry of Health last year, - [EUCOPE Pricing & Reimbursement / Market Access WG Meeting, 12 February | HTA Network Stakeholder Pool Meeting: minutes | Impact HTA Project: study to construct novel multicriteria HTA framework](https://www.eucope.org/membersonly/eucope-pricing-reimbursement-market-access-wg-meeting-12-february-hta-network-stakeholder-pool-meeting-minutes-impact-hta-project-study-to-construct-novel-multicriteria-hta-framework/) - Dear Members, With this email, we would like to kindly remind you of the upcoming P&R / Market Access Working Group meeting, share the minutes of the last HTA Network Stakeholder Pool meeting and inform you of an opportunity for EUCOPE to partake in an ‘Impact HTA Project’ study towards building a novel multicriteria HTA - [Commission Consultation on applications for designation as OMP | Statement on Paediatric Regulation](https://www.eucope.org/membersonly/commission-consultation-on-applications-for-designation-as-omp-statement-on-paediatric-regulation/) - Dear Members, With this email, we are sharing with you a consultation on the format and content of applications for designations as OMPs and a statement document on the Paediatric Regulation. Guidelines on the format and content of applications for designation as orphan medicinal products (OMPs) and on the transfer of designations – targeted consultation - [EMA Industry Stakeholder meeting on Brexit I Consultation on electronic product information (ePI)](https://www.eucope.org/membersonly/ema-industry-stakeholder-meeting-on-brexit-i-consultation-on-electronic-product-information-epi/) - Dear Members, Please find in the following the latest information on Brexit related implications for the pharmaceutical industry based on the EMA Industry Stakeholder meeting on Brexit as well as information on a public consultation on the draft principles on the electronic product information for human medicines. Brexit Related Implications for the Pharmaceutical Industry At the - [EUCOPE Members Meeting Agenda, 26 February, Brussels | EURORDIS Multi-stakeholder Symposium, 13-14 February, Brussels](https://www.eucope.org/membersonly/eucope-members-meeting-agenda-26-february-brussels-eurordis-multi-stakeholder-symposium-13-14-february-brussels/) - Dear Members, In this email, we would like to share with you the agenda of the next Members Meeting and to invite you to mark your calendars for the yearly Multi-stakeholder Symposium of EURORDIS. EUCOPE Members Meeting, 26 February, Brussels We are delighted to invite you to the first Members Meeting of the year, which - [OMP WG Meeting Agenda - 6 February, Brussels | DIA Conference - 5 to 7 February, Vienna](https://www.eucope.org/membersonly/omp-wg-meeting-agenda-6-february-brussels-dia-conference-5-to-7-february-vienna/) - Dear Members, With this email, we would like to invite you to the next meeting of the OMP Working Group, held on 6 February at our premises, as well as inform you of an upcoming Orphan Medicinal Products Working Group Meeting: 6 February, Brussels On 6 February, the OMP Working Group will meet for the - [P&R/Market Access Working Group 12/02, Brussels - Meeting with Polish Agencies on 22/01, Warsaw](https://www.eucope.org/membersonly/pr-market-access-working-group-12-02-brussels-meeting-with-polish-agencies-on-22-01-warsaw/) - Dear Members, Please find attached the agenda of the next Pricing & Reimbursement/Market Access Working Group Meeting on 12 February as well as some information regarding the meeting with the Polish Regulatory and HTA Agencies on 22 January. Furthermore, please find also attached the slide deck presented at the EUCOPE meeting with the Danish Medicines - [EUCOPE meeting with the Polish Agencies for Registration and for HTA: 22 January](https://www.eucope.org/membersonly/eucope-meeting-with-the-polish-agencies-for-registration-and-for-hta-22-january/) - Dear Members, With this new year starting, we wish you all a most happy and successful 2019! To kick off EUCOPE’s 2019 activities, we would like to provide more information regarding EUCOPE’s meeting with the Polish agencies, on 22 January 2019. EUCOPE meeting with the Polish Agencies for Registration and for HTA – 22 January, - [Allergen Immunotherapy for children | EU CT database and portal | Survey EMA engagement | EMA patient registries | CMDh meeting minutes](https://www.eucope.org/membersonly/allergen-immunotherapy-for-children-i-eu-ct-database-and-portal-i-survey-ema-engagement-i-ema-patient-registries-i-cmdh-meeting-minutes/) - Dear Members, Please find in the following information on upcoming and past EMA meetings as well as two important public consultations and the minutes of the CMDh meeting with Interested parties attached. Allergen Immunotherapy (AIT) for children – PDCO meeting - 16 Jan 2019 The EMA’s Paediatric Committee (PDCO) invites manufacturers of allergen products for - [EUCOPE Legal Working Group Slides | EUCOPE Position Paper on Gene & Cell Therapies | EMVS Master Data Guide](https://www.eucope.org/membersonly/eucope-legal-working-group-slides-eucope-position-paper-on-gene-cell-therapies-emvs-master-data-guide/) - Dear Members, We are happy to share with you the slide-deck presented at the last EUCOPE Legal Working Group Meeting as well as the finalised EUCOPE Position Paper on Gene & Cell Therapies. Furthermore, please find attached an amended version of the European Medicines Verification System (EMVS) Master Data Guide. EUCOPE Legal Working Group Meeting - [New bill in Germany introducing registries for OMPs and biosimilars uptake](https://www.eucope.org/membersonly/new-bill-in-germany-introducing-registries-for-omps-and-biosimilars-uptake/) - Dear Members, The German Ministry of Health recently released a bill with significant impact on OMPs, ATMPs, biologics (biosimilar uptake) among other things. The bill might be amended in parts and could potentially take effect in the first half of 2019 (in most parts). It contains the following proposals: New calculation of 50 Mio. OMP - [Brexit: Withdrawal Agreement and Political Declaration - Contingency Planning remains crucial](https://www.eucope.org/membersonly/brexit-withdrawal-agreement-and-political-declaration-contingency-planning-remains-crucial/) - Dear Members, On the 25th of November, the EU Member States have approved the Agreement on the Withdrawal of the UK from the EU as well as a Political Declaration setting out the framework for the future relationship. Whereas the Agreement is a legally binding document setting out the terms of the UK's exit from - [EMA Industry stakeholder meetings I Draft Agenda Regulatory, Pharmacovigilance, Medical Device Working Group I DIA Europe](https://www.eucope.org/membersonly/ema-industry-stakeholder-meetings-i-draft-agenda-regulatory-pharmacovigilance-medical-device-working-group-i-dia-europe/) - Dear Members, We would like to provide you with a brief summary of the latest Industry stakeholder meetings at the EMA, namely: the platform on research and development (R&D) support, the workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies and the workshop to launch consultation on EMA - [Agenda Gene & Cell Therapy WG meeting 22 Nov | Upcoming national meetings in Denmark and Poland](https://www.eucope.org/membersonly/agenda-gene-cell-therapy-wg-meeting-22-nov-upcoming-national-meetings-in-denmark-and-poland/) - Dear Members of the Gene & Cell therapy working group, We are pleased to finally share with you the agenda for the upcoming Gene & Cell Therapy working group meeting scheduled on Thursday 22 November from 12.00 until 5pm CET at our premises: rue Marie de Bourgogne 58, 1000 Brussels. Kindly refer to the enclosed - [MDR / IVDR implementation | Call for interest MDCG expert group - deadline | Conference: combination products under the MDR - 19 November, Brussels | EUCOPE Regulatory / PV / MD teleconference - 13 November](https://www.eucope.org/membersonly/mdr-ivdr-implementation-call-for-interest-mdcg-expert-group-deadline-conference-combination-products-under-the-mdr-19-november-brussels-eucope-regulatory-pv-md-teleconference-13-no/) - Dear Members, In this email, you will find the latest information about the implementation of the Medical Devices Regulation (MDR) and in-vitro diagnostics Regulation (IVDR). We are also calling for volunteers to represent EUCOPE as an industry stakeholder in the newly-created Medical Devices Coordination Group (MDCG). You will also find attached the draft agenda for - [Agenda Market Access / P&R meeting - 20 November | EUCOPE meeting in Copenhagen - 7 December | Reminder Patient Access Europe Summit - 30 Oct](https://www.eucope.org/membersonly/agenda-market-access-pr-meeting-20-november-eucope-meeting-in-copenhagen-7-december-reminder-patient-access-europe-summit-30-oct/) - Dear Members, We are pleased to share with you the agenda of our upcoming Market Access / Pricing & Reimbursement working group meeting as well as further details on our encounter with the Danish Health Authorities in Copenhagen scheduled in December. Additionally, we wish to remind you about the MAP BioPharma-EUCOPE Patient Access Europe Summit - [Regulatory Challenges for Nanomedicines](https://www.eucope.org/membersonly/regulatory-challenges-for-nanomedicines/) - Dear Members, Recently, member companies have made us aware of the challenges nanomedicines are facing in relation to the current regulatory framework and in particular its unsuitability for follow-on nanomedicines. Nanomedicines are medicinal products that have at least one dimension in the nanoscale range (1nm to 100nm). The small size of nanomedicines allows for preferential - [Brexit Update: Check List & Minutes of EMA Industry Stakeholder Meeting](https://www.eucope.org/membersonly/brexit-update-check-list-minutes-of-ema-industry-stakeholder-meeting/) - Dear Members, As you are aware, a positive outcome of the Brexit negotiations and the ratification of a possible deal remains highly uncertain. Therefore, the EU 27 and the UK have lately further emphasised the need for contingency planning. In late August, the UK government has published a Guidance on how to prepare for Brexit - [Technopolis Survey for a study on the EU Orphan Regulation - Deadline for responses: 14 November 2018](https://www.eucope.org/membersonly/technopolis-survey-for-a-study-on-the-eu-orphan-regulation-deadline-for-responses-14-november-2018/) - Dear Members, You will find hereafter a link to a survey for the study supporting the evaluation of the EU Orphan Regulation, sponsored by the European Commission and conducted by the consultancy Technopolis, to be filled in by 14 November 2018: https://www.research.net/r/OMP_developers. For ease of reference, you shall also find the survey questions in the - [EUCOPE OMP Working Group meeting - slide-deck | EU Commission / EMA Workshop on the Paediatric Regulation - 20 March, London](https://www.eucope.org/membersonly/eucope-omp-working-group-meeting-slide-deck-eu-commission-ema-workshop-on-the-paediatric-regulation-20-march-london/) - Dear Members, In this email, you will find information about the OMP WG meeting organised on 23 January, as well as the upcoming workshop co-organised by the EU Commission and the EMA on the Paediatric Regulation, on 20 March. 1. EUCOPE OMP WG meeting, 23 January Discussions of the Orphan Medicinal Products Working Group revolved ## Members - [Rocket Pharmaceuticals](https://www.eucope.org/eucopemembers/rocket-pharmaceuticals/) - [MediWound](https://www.eucope.org/eucopemembers/mediwound/) - [Dyne Therapeutics](https://www.eucope.org/eucopemembers/dyne-therapeutics/) - [Deciphera](https://www.eucope.org/eucopemembers/deciphera/) - [Morgan Lewis](https://www.eucope.org/eucopemembers/morgan-lewis/) - [WinQure](https://www.eucope.org/eucopemembers/winqure/) - [Astellas](https://www.eucope.org/eucopemembers/astellas/) - [WuXi AppTec](https://www.eucope.org/eucopemembers/wuxi-apptec/) - [H A C Pharma](https://www.eucope.org/eucopemembers/h-a-c-pharma/) - [Ecker + Ecker](https://www.eucope.org/eucopemembers/ecker-ecker-2/) - [BlueDil](https://www.eucope.org/eucopemembers/bluedil/) - [A&O Shearman](https://www.eucope.org/eucopemembers/allen-overy/) - [SCIRIS](https://www.eucope.org/eucopemembers/sciris/) - [CSL](https://www.eucope.org/eucopemembers/csl-behring/) - [Orphan Europe](https://www.eucope.org/eucopemembers/orphan-europe/) - [France Biotech](https://www.eucope.org/eucopemembers/france-biotech/) - [Evoke Incisive Health](https://www.eucope.org/eucopemembers/evoke-incisive-health/) - [Dipharma SA](https://www.eucope.org/eucopemembers/dipharma-sa/) - [Argenx](https://www.eucope.org/eucopemembers/argenx/) - [Apellis](https://www.eucope.org/eucopemembers/apellis/) - [TETEC](https://www.eucope.org/eucopemembers/tetec/) - [Rhythm](https://www.eucope.org/eucopemembers/rhythm/) - [BeOne](https://www.eucope.org/eucopemembers/beigene/) - [Madrigal](https://www.eucope.org/eucopemembers/madrigal/) - [inventiva](https://www.eucope.org/eucopemembers/inventiva/) - [Burson](https://www.eucope.org/eucopemembers/burson/) - [Ascendis](https://www.eucope.org/eucopemembers/ascendis/) - [SIGA](https://www.eucope.org/eucopemembers/siga/) - [Thermo Fisher Scientific](https://www.eucope.org/eucopemembers/thermo-fisher-scientific/) - [Crinetics Pharmaceuticals](https://www.eucope.org/eucopemembers/crinetics-pharmaceuticals/) - [Regulatory Pharma Net](https://www.eucope.org/eucopemembers/regulatory-pharma-net/) - [Bridge Bio](https://www.eucope.org/eucopemembers/bridge-bio/) - [Egetis Therapeutics](https://www.eucope.org/eucopemembers/egetis-therapeutics/) - [EveryONE Medicines](https://www.eucope.org/eucopemembers/everyone-medicines/) - [Soleno Therapeutics](https://www.eucope.org/eucopemembers/soleno-therapeutics/) - [APCO Worldwide](https://www.eucope.org/eucopemembers/apco-worldwide/) - [Orion Pharma](https://www.eucope.org/eucopemembers/orion/) - [Kintiga](https://www.eucope.org/eucopemembers/skc-beratung/) - [Edelman Public & Government Affairs](https://www.eucope.org/eucopemembers/edelman/) - [AzurBio Pharma](https://www.eucope.org/eucopemembers/5302/) - [Acadia Pharmaceuticals](https://www.eucope.org/eucopemembers/acadia-pharmaceuticals/) - [Decisive Consulting](https://www.eucope.org/eucopemembers/decisive-consulting/) - [Avidity Biosciences](https://www.eucope.org/eucopemembers/avidity-biosciences/) - [GE HealthCare](https://www.eucope.org/eucopemembers/ge-healthcare/) - [SERB Pharmaceuticals](https://www.eucope.org/eucopemembers/serb-pharmaceuticals/) - [CureVac](https://www.eucope.org/eucopemembers/curevac/) - [Alcon](https://www.eucope.org/eucopemembers/alcon/) - [ITM Radiopharma](https://www.eucope.org/eucopemembers/itm-radiopharma/) - [Regeneron](https://www.eucope.org/eucopemembers/regeneron/) - [medac](https://www.eucope.org/eucopemembers/medac/) - [Inbeeo](https://www.eucope.org/eucopemembers/inbeeo/) - [MÖHRLE HAPP LUTHER](https://www.eucope.org/eucopemembers/mohrle-happ-luther/) - [Sumitomo Pharma](https://www.eucope.org/eucopemembers/sumitomo-pharma/) - [Menarini](https://www.eucope.org/eucopemembers/stemline/) - [Ipsen](https://www.eucope.org/eucopemembers/ipsen/) - [BioNTech](https://www.eucope.org/eucopemembers/biontech/) - [Hellenic Association of Pharmaceutical Companies](https://www.eucope.org/eucopemembers/hellenic-association-of-pharmaceutical-companies/) - [Labcorp](https://www.eucope.org/eucopemembers/labcorp/) - [Angelini](https://www.eucope.org/eucopemembers/angelini/) - [Pharvaris](https://www.eucope.org/eucopemembers/pharvaris/) - [MassBio](https://www.eucope.org/eucopemembers/massbio/) - [Metriopharm AG](https://www.eucope.org/eucopemembers/metriopharm-ag/) - [Pharming Group](https://www.eucope.org/eucopemembers/pharming-group/) - [Acumen](https://www.eucope.org/eucopemembers/acumen/) - [MaaT Pharma](https://www.eucope.org/eucopemembers/maat-pharma/) - [Emergent Biosolutions](https://www.eucope.org/eucopemembers/emergent-biosolutions/) - [Insmed](https://www.eucope.org/eucopemembers/insmed/) - [Avanzanite Bioscience](https://www.eucope.org/eucopemembers/avanzanite-bioscience/) - [Admedicum](https://www.eucope.org/eucopemembers/admedicum/) - [Lif SE](https://www.eucope.org/eucopemembers/lif-se/) - [MSD](https://www.eucope.org/eucopemembers/msd/) - [Moderna](https://www.eucope.org/eucopemembers/moderna/) - [Genesis Pharma Group](https://www.eucope.org/eucopemembers/genesis-pharma-group/) - [Dierks + Company](https://www.eucope.org/eucopemembers/dierks-company/) - [Alexion Pharmaceuticals](https://www.eucope.org/eucopemembers/alexion-pharmaceuticals/) - [Bavarian Nordic](https://www.eucope.org/eucopemembers/bavarian-nordic/) - [Arnold & Porter](https://www.eucope.org/eucopemembers/arnold-porter/) - [Flatiron Health](https://www.eucope.org/eucopemembers/flatiron-health/) - [AOP Health](https://www.eucope.org/eucopemembers/aop-health/) - [Novo Nordisk](https://www.eucope.org/eucopemembers/novo-nordisk/) - [Sanofi](https://www.eucope.org/eucopemembers/sanofi/) - [Dentons Global Advisory - Interel](https://www.eucope.org/eucopemembers/dentonsinterel/) - [Circius Pharma](https://www.eucope.org/eucopemembers/circius-pharma/) - [Eversana](https://www.eucope.org/eucopemembers/eversana/) - [Orphalan](https://www.eucope.org/eucopemembers/orphalan/) - [Organon](https://www.eucope.org/eucopemembers/organon/) - [Travere Therapeutics](https://www.eucope.org/eucopemembers/travere-therapeutics/) - [Latham & Watkins LLP](https://www.eucope.org/eucopemembers/latham-watkins-llp/) - [Chiesi](https://www.eucope.org/eucopemembers/chiesi/) - [Weber Shandwick](https://www.eucope.org/eucopemembers/weber-shandwick/) - [BMS](https://www.eucope.org/eucopemembers/bristol-myers-squibb/) - [Illumina](https://www.eucope.org/eucopemembers/illumina/) - [BioCryst](https://www.eucope.org/eucopemembers/biocryst/) - [Concilius](https://www.eucope.org/eucopemembers/concilius/) - [King & Spalding](https://www.eucope.org/eucopemembers/king-spalding/) - [Blueprint Medicines](https://www.eucope.org/eucopemembers/blueprint-medicines/) - [Guardant Health](https://www.eucope.org/eucopemembers/guardant-health/) - [Partners4Access](https://www.eucope.org/eucopemembers/partners4access/) - [Genmab](https://www.eucope.org/eucopemembers/genmab/) - [Heel Biologische Heilmittel](https://www.eucope.org/eucopemembers/biologische-heilmittel-heel/) - [Exact Sciences](https://www.eucope.org/eucopemembers/exact-sciences/) - [Shionogi](https://www.eucope.org/eucopemembers/shionogi/) - [Novartis](https://www.eucope.org/eucopemembers/novartis/) - [Mereo BioPharma](https://www.eucope.org/eucopemembers/mereo-biopharma/) - [Ferrer](https://www.eucope.org/eucopemembers/ferrer/) - [SmartStep](https://www.eucope.org/eucopemembers/smartstep/) - [MedVance](https://www.eucope.org/eucopemembers/medvance/) - [Orchard therapeutics](https://www.eucope.org/eucopemembers/orchard-therapeutics/) - [Ovid Therapeutics](https://www.eucope.org/eucopemembers/ovid-therapeutics/) - [Schwabe Pharma](https://www.eucope.org/eucopemembers/schwabe-pharma/) - [Amgen](https://www.eucope.org/eucopemembers/amgen/) - [Vertex Pharmaceuticals](https://www.eucope.org/eucopemembers/vertex-pharmaceuticals/) - [Jazz Pharmaceuticals](https://www.eucope.org/eucopemembers/jazz-pharmaceuticals/) - [Incyte Biosciences](https://www.eucope.org/eucopemembers/incyte-biosciences/) - [Sarepta Therapeutics](https://www.eucope.org/eucopemembers/sarepta-therapeutics/) - [Miltenyi Biotec](https://www.eucope.org/eucopemembers/miltenyi-biotec/) - [Intercept Pharmaceuticals](https://www.eucope.org/eucopemembers/intercept-pharmaceuticals/) - [Tutogen](https://www.eucope.org/eucopemembers/tutogen/) - [Grifols](https://www.eucope.org/eucopemembers/grifols/) - [BioMarin Pharmaceutical Inc](https://www.eucope.org/eucopemembers/biomarin-pharmaceutical-inc/) - [Norgine](https://www.eucope.org/eucopemembers/norgine/) - [Zealand Pharma](https://www.eucope.org/eucopemembers/zealand-pharma/) - [WilmerHale](https://www.eucope.org/eucopemembers/wilmerhale/) - [Vianex](https://www.eucope.org/eucopemembers/vianex/) - [Ultragenyx](https://www.eucope.org/eucopemembers/ultragenyx/) - [Takeda Pharmaceuticals](https://www.eucope.org/eucopemembers/takeda-pharmaceuticals/) - [Swedish Orphan Biovitrum](https://www.eucope.org/eucopemembers/swedish-orphan-biovitrum/) - [Sotio](https://www.eucope.org/eucopemembers/sotio/) - [Sidley Austin](https://www.eucope.org/eucopemembers/sidley-austin/) - [Santen](https://www.eucope.org/eucopemembers/santen/) - [PTC Therapeutics](https://www.eucope.org/eucopemembers/ptc-therapeutics/) - [PharmaLex](https://www.eucope.org/eucopemembers/pharmalex/) - [Medice](https://www.eucope.org/eucopemembers/medice/) - [Kite Pharma](https://www.eucope.org/eucopemembers/kite-pharma/) - [IGES Institut](https://www.eucope.org/eucopemembers/iges-institut/) - [Hogan Lovells](https://www.eucope.org/eucopemembers/hogan-lovells/) - [FTI Consulting](https://www.eucope.org/eucopemembers/fti-consulting/) - [Ferring](https://www.eucope.org/eucopemembers/ferring/) - [Ethical Medicines Industry Group (EMIG)](https://www.eucope.org/eucopemembers/ethical-medicines-industry-group-emig/) - [EffRx pharmaceutical](https://www.eucope.org/eucopemembers/effrx-pharmaceutical/) - [D+B](https://www.eucope.org/eucopemembers/db/) - [Cytokinetics](https://www.eucope.org/eucopemembers/cytokinetics/) - [Covington Burling](https://www.eucope.org/eucopemembers/covington-burling/) - [Bundesverband der Pharmazeutischen Industrie e.V. (BPI)](https://www.eucope.org/eucopemembers/bundesverband-der-pharmazeutischen-industrie-e-v-bpi/) - [Bird & Bird](https://www.eucope.org/eucopemembers/bird-bird/) - [Biotest AG](https://www.eucope.org/eucopemembers/biotest-ag/) - [Biogen](https://www.eucope.org/eucopemembers/biogen/) - [BIO Deutschland e.V.](https://www.eucope.org/eucopemembers/bio-deutschland-e-v/) - [Alnylam Pharmaceuticals](https://www.eucope.org/eucopemembers/alnylam-pharmaceuticals/) - [AMS Advanced Medical Services GmbH](https://www.eucope.org/eucopemembers/ams-advanced-medical-services-gmbh/) ## Resources - [Study on Economic Contribution of EUCOPE Membership and Trade Implications of U.S. Policy Measures](https://www.eucope.org/dpi_resources/study-on-economic-contribution-of-eucope-membership-and-trade-implications-of-u-s-policy-measures/) - ECONOMIC CONTRIBUTION OF EUCOPE’S MEMBERSHIP AND TRADE IMPLICATIONS FOLLOWING U.S. POLICY MEASURES EUCOPE’s membership survey - [EUCOPE White Paper on ATMP Manufacturing](https://www.eucope.org/dpi_resources/eucope-white-paper-on-atmp-manufacturing/) - To facilitate ATMP manufacturing in the EU both legislative and non-legislative solutions are needed. EUCOPE puts forward a number of solutions in 5 key areas. - [EUCOPE White Paper - The Role of Advanced Diagnostics in Shaping the Future of the EU Biotech Landscape](https://www.eucope.org/dpi_resources/eucope-white-paper-the-role-of-advanced-diagnostics-in-shaping-the-future-of-the-eu-biotech-landscape/) - The White Paper addressed current gaps in the EU and explaines why investment in advanced diagnostics should be prioritised as part of the new EU Biotech Act. - [Fostering Innovation in Paediatric Medicines - Creating a Competitive Framework in the EU](https://www.eucope.org/dpi_resources/fostering-innovation-in-paediatric-medicines-creating-a-competitive-framework-in-the-eu/) - This paper outlines the value of innovaiton in paeditric medicines and the importance of creating a competitive framework in the EU for paediatric medicines. - [THE FUTURE OF HEALTHCARE: ADVANCING SCREENING AND TESTING IN ONCOLOGY, ATMPS, AND RARE DISEASES](https://www.eucope.org/dpi_resources/the-future-of-healthcare-advancing-screening-and-testing-in-oncology-atmps-and-rare-diseases/) - This paper outlines the value of advanced diagnostics in improving patient outcomes, supporting healthcare system sustainability, and accelerating R&D efforts. - [Incentives for Development of and Access to Antimicrobials - Recommendations for the EU's response to the AMR Crisis](https://www.eucope.org/dpi_resources/incentives-for-development-of-and-access-to-antimicrobials-recommendations-for-the-eus-response-to-the-amr-crisis/) - This Position Paper outlines EUCOPE’s views and recommendations of incentives and policies to support a sustainable market for antimicrobials in the EU. - [European Biotech Act | How to Ensure the Biopharmaceutical Sector Thrives in the EU](https://www.eucope.org/dpi_resources/european-biotech-act-how-to-ensure-the-biopharmaceutical-sector-thrives-in-the-eu/) - [EU Health Preparedness: A strong mandate for HERA - EUCOPE recommendations](https://www.eucope.org/dpi_resources/eu-health-preparedness-a-strong-mandate-for-hera-eucope-recommendations/) - [The Potential of Liquid Biopsy in Cancer Care](https://www.eucope.org/dpi_resources/the-potential-of-liquid-biopsy-in-cancer-care/) - [The Economic Lens: Understanding What Makes the EU Attractive for Life Sciences](https://www.eucope.org/dpi_resources/understanding-what-makes-the-eu-attractive-for-life-sciences/) - The report explores the EU’s ability to attract life sciences investments, specifically for rare diseases, and the impact of the pharmaceutical package . - [Hospital Exemption Clause in ATMPs (2024)](https://www.eucope.org/dpi_resources/hospital-exemption-clause-in-atmps-2023/) - EUCOPE proposes recommendations for the good practice of hospital exemption, for the benefit of science, research, and ultimately, patients in Europe. - [Life science industry concerns over workability of EU HTA](https://www.eucope.org/dpi_resources/life-science-industry-concerns-over-workability-of-eu-hta/) - Life science industry concerns over the workability of EU HTA: EU cannot miss out on the opportunity to speed up access to innovative medicines for patients - [Life Science Lectures - Episode Four](https://www.eucope.org/dpi_resources/life-science-lectures-episode-four/) - [Life Science Lectures - Episode One](https://www.eucope.org/dpi_resources/life-science-lectures-episode-one/) - [Life Science Lectures - Episode Two](https://www.eucope.org/dpi_resources/life-science-lectures-episode-two-defining-high-unmet-medical-need/) - [Life Science Lectures - Episode Three](https://www.eucope.org/dpi_resources/life-science-lectures-episode-three/) - [EU Pharmaceutical Package: A more competitive and attractive EU for smaller companies](https://www.eucope.org/dpi_resources/eu-pharmaceutical-package-a-more-competitive-and-attractive-eu-for-smaller-companies/) - [Episode 17 - Real-World Evidence (RWE): The need for a multi-stakeholder approach](https://www.eucope.org/dpi_resources/episode-17-real-world-evidence-rwe-the-need-for-a-multi-stakeholder-approach/) - [EUCOPE launches the European Coalition for Access to Comprehensive Genomic Profiling (ECGP)](https://www.eucope.org/dpi_resources/eucope-launches-the-european-coalition-for-access-to-comprehensive-genomic-profiling-ecgp/) - [EU-wide Stockpiling: Better Preparedness for Cross-Border Health Threats](https://www.eucope.org/dpi_resources/eu-wide-stockpiling-better-preparedness-for-cross-border-health-threats/) - [Episode 16 - Rare Reflections: Impact of OMP Revision on rare disease companies](https://www.eucope.org/dpi_resources/episode-16-rare-reflections-impact-of-omp-revision-on-rare-disease-companies/) - [Episode 15 - MDR/IVDR Amendments: Implications for EU medical device companies and patients](https://www.eucope.org/dpi_resources/episode-15-mdr-ivdr-amendments-implications-for-eu-medical-device-companies-and-patients/) - [Drastic Changes in Europe’s 1st Launch Country: How recent legislative changes impact the German P&R landscape](https://www.eucope.org/dpi_resources/drastic-changes-in-europes-1st-launch-country-how-recent-legislative-changes-impact-the-german-pr-landscape/) - [Episode 14 - Trans-Atlantic Innovation: Building bridges between the EU & US life sciences industry](https://www.eucope.org/dpi_resources/episode-14-trans-atlantic-innovation-building-bridges-between-the-eu-us-life-sciences-industry/) - [Policy Brief | The OMP Regulation](https://www.eucope.org/dpi_resources/policy-brief-the-omp-regulation/) - [Orphan Medicinal Products Legislation: The Way Forward (2021)](https://www.eucope.org/dpi_resources/orphan-medicinal-products-legislation-the-way-forward-2021/) - [Rare Disease Day 2023: A Shared Vision for the EU Rare Disease Ecosystem](https://www.eucope.org/dpi_resources/rare-disease-day-2023-a-shared-vision-for-the-eu-rare-disease-ecosystem/) - [Episode 13 - Rare Disease Day 2023](https://www.eucope.org/dpi_resources/episode-13-rare-disease-day-2023/) - [Real-World Evidence (RWE) across the Lifecycle of Cell and Gene Therapies (2023)](https://www.eucope.org/dpi_resources/real-world-evidence-rwe-across-the-lifecycle-of-cell-and-gene-therapies-2023/) - [Launch Conditionality: What's at Stake?](https://www.eucope.org/dpi_resources/launch-conditionality-whats-at-stake/) - [World Cancer Day: Fostering the EU Advanced Diagnostics Ecosystem to tackle the Cancer Burden](https://www.eucope.org/dpi_resources/world-cancer-day-fostering-the-eu-advanced-diagnostics-ecosystem-to-tackle-the-cancer-burden/) - [Episode 12 - Preparing for the new EU HTA Procedure](https://www.eucope.org/dpi_resources/episode-12-preparing-for-the-new-eu-hta-procedure/) - [Episode 11 - 2022 Year in Review](https://www.eucope.org/dpi_resources/episode-11-2022-year-in-review/) - [Episode 10 - Launch Conditionality: The impact on small and mid-sized companies](https://www.eucope.org/dpi_resources/episode-10-launch-conditionality-the-impact-on-small-and-mid-sized-companies/) - [Concerns over the Implementation of the EU HTA Regulation](https://www.eucope.org/dpi_resources/concerns-over-the-implementation-of-the-eu-hta-regulation/) - [Policy Brief | The EU HTA Procedure](https://www.eucope.org/dpi_resources/policy-brief-the-eu-hta-procedure/) - [Episode 9 - ATMPs and how they'll be impacted by the General Pharmaceutical Legislation](https://www.eucope.org/dpi_resources/episode-9-atmps-and-how-theyll-be-impacted-by-the-general-pharmaceutical-legislation/) - [European Health Data Space (EHDS): How will it impact health technology companies operating in or about to enter the EU?](https://www.eucope.org/dpi_resources/european-health-data-space-ehds-how-will-it-impact-health-technology-companies-operating-in-or-about-to-enter-the-eu/) - [Episode 6 - Overcoming Barriers: Improving Access for Rare Disease Patients through Cross-Border Healthcare (2022)](https://www.eucope.org/dpi_resources/episode-6-overcoming-barriers-improving-access-for-rare-disease-patients-through-cross-border-healthcare/) - [Event Report: The revision of the EU legal framework for orphan drugs and its impact on Germany](https://www.eucope.org/dpi_resources/event-report-the-revision-of-the-eu-legal-framework-for-orphan-drugs-and-its-impact-on-germany/) - [Episode 8 - Ensuring a robust European Health Data Space (EHDS)](https://www.eucope.org/dpi_resources/episode-8-ensuring-a-robust-european-health-data-space-ehds/) - [Episode 7 - Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas](https://www.eucope.org/dpi_resources/episode7-unmetmedicalneeds/) - [Patient Centricity and the Science of Patient Input (2021)](https://www.eucope.org/dpi_resources/patient-centricity-and-the-science-of-patient-input-2021/) - [Episode 2 - Fostering an EU Advanced Diagnostics Ecosystem (2021)](https://www.eucope.org/dpi_resources/episode-2-fostering-an-eu-advanced-diagnostics-ecosystem-2021/) - [Episode 1 - A Future-proof HTA System in Europe? (2021)](https://www.eucope.org/dpi_resources/episode-1-a-future-proof-hta-system-in-europe-2021/) - [Episode 3 - The European Pharmaceutical Strategy: A patient-centred and future-proof framework? (2021)](https://www.eucope.org/dpi_resources/episode-3-the-european-pharmaceutical-strategy-a-patient-centred-and-future-proof-framework-2021/) - [Episode 4 - What's next for EU Rare Disease Legislation? Its potential implications for patients and pharma entrepreneurs (2021)](https://www.eucope.org/dpi_resources/episode-4-whats-next-for-eu-rare-disease-legislation-its-potential-implications-for-patients-and-pharma-entrepreneurs-2021/) - [Episode 5 - Increasing Access to Genomic Testing in Europe: The role of national genomics initiatives in increasing uptake of Advanced Diagnostics](https://www.eucope.org/dpi_resources/episode-5-increasing-access-to-genomic-testing-in-europe/) - [Fostering Innovative Therapies and Technologies in Europe: A Forward Look (2021)](https://www.eucope.org/dpi_resources/fostering-innovative-therapies-and-technologies-in-europe-a-forward-look-2021/) - [Five Priorities for a Successful EU HTA Procedure](https://www.eucope.org/dpi_resources/five-priorities-for-a-successful-eu-hta-procedure/) - [The Modernisation of the Centralised Procedure (2022)](https://www.eucope.org/dpi_resources/the-modernisation-of-the-centralised-procedure-2022/) - [EUCOPE's 5 EU HTA Priorities (2022)](https://www.eucope.org/dpi_resources/eucopes-5-eu-hta-priorities-2022/) - [Compounding Drugs to Lower Costs Puts Patients at Risk (2017)](https://www.eucope.org/dpi_resources/compounding-drugs-to-lower-costs-puts-patients-at-risk-2017/) - [Compounding Drugs to Lower Costs Puts Patients at Risk (2016)](https://www.eucope.org/dpi_resources/compounding-drugs-to-lower-costs-puts-patients-at-risk-2016/) - [European Health Forum Gastein: A better tomorrow for rare disease care and research (2021)](https://www.eucope.org/dpi_resources/european-health-forum-gastein-a-better-tomorrow-for-rare-disease-care-and-research-2021/) - [EUCOPE/IML roundtable ‘Revision of the European Orphan & Paediatric Regulation and impact for the Nordic rare disease community’](https://www.eucope.org/dpi_resources/eucope-iml-roundtable-revision-of-the-european-orphan-paediatric-regulation-and-impact-for-the-nordic-rare-disease-community/) - [The Future of Rare Diseases in Sweden & Denmark (2021)](https://www.eucope.org/dpi_resources/the-future-of-rare-diseases-in-sweden-denmark-2021/) - [Health 4.0. post-COVID - Small and Medium Companies Leading Innovation](https://www.eucope.org/dpi_resources/health-4-0-post-covid-small-and-medium-companies-leading-innovation/) - [Pulling out all the stops to deliver high-quality care for European cancer patients (2021)](https://www.eucope.org/dpi_resources/pulling-out-all-the-stops-to-deliver-high-quality-care-for-european-cancer-patients-2021/) - [EC Pharmaceutical Strategy – Time for a Modern Approach to Value (2020)](https://www.eucope.org/dpi_resources/ec-pharmaceutical-strategy-time-for-a-modern-approach-to-value-2020/) - [On the EU's General Pharmaceutical Legislation](https://www.eucope.org/dpi_resources/on-the-eus-general-pharmaceutical-legislation/) - [Statement on EU HTA Portuguese Presidency Compromise (2021)](https://www.eucope.org/dpi_resources/statement-on-eu-hta-portuguese-presidency-compromise-2021/) - [Developing an Advanced Diagnostics Ecosystem in Europe (2021)](https://www.eucope.org/dpi_resources/developing-an-advanced-diagnostics-ecosystem-in-europe-2021/) - [In Vitro Diagnostic Medical Devices (2013)](https://www.eucope.org/dpi_resources/in-vitro-diagnostic-medical-devices-2013/) - [Medical Devices Regulation (2015)](https://www.eucope.org/dpi_resources/medical-devices-regulation-2015/) - [Cross-Border Healthcare for Rare Disease Patients: What Can Be Done? (2021)](https://www.eucope.org/dpi_resources/cross-border-healthcare-for-rare-disease-patients-what-can-be-done-2021/) - [ATMPs: New Payment & Funding Approaches (2021)](https://www.eucope.org/dpi_resources/atmps-new-payment-funding-approaches-2021/) - EUCOPE calls for a coherent approach to establish outcome-based models, increase the use of Real-World Evidence and set up specific ATMPs funds within the healthcare systems. - [The Revision of the EU Regulations on medicines for children and rare diseases (2021)](https://www.eucope.org/dpi_resources/the-revision-of-the-eu-regulations-on-medicines-for-children-and-rare-diseases-2021/) - [The EU Paediatric Regulation: Our Proposals in Brief (2021)](https://www.eucope.org/dpi_resources/the-eu-paediatric-regulation-our-proposals-in-brief-2021/) - [The EU Paediatric Regulation: Innovation for our Future (2021)](https://www.eucope.org/dpi_resources/the-eu-paediatric-regulation-innovation-for-our-future-2021/) - [Life Science Industry Coalition on BREXIT](https://www.eucope.org/dpi_resources/life-science-industry-coalition-on-brexit/) - [Joint Price Negotiations for Medicines (2015)](https://www.eucope.org/dpi_resources/on-joint-price-negotiations-for-medicines/) - EUCOPE's Position on Joint Price Negotiations for Medicines - [On Commission’s proposal for a Regulation on HTA (2018)](https://www.eucope.org/dpi_resources/on-commissions-proposal-for-a-regulation-on-hta-2018/) - The pharmaceutical industry's statement on strengthening the process and methodology framework within the main body of the HTA Regulation. - [Differences in Pharmaceutical Prices between Member States (2012)](https://www.eucope.org/dpi_resources/pharmaceutical-prices-why-are-there-differences-between-member-states/) - This paper aims to explain the reasons for price differences between Member States. - [EU Paediatric Regulation (2017)](https://www.eucope.org/dpi_resources/eu-paediatric-regulation-2017/) - EUCOPE proposes changes to certain aspects of the Paediatric Regulation that has resulted in unnecessary complexities. - [EU Cooperation on HTA (2018)](https://www.eucope.org/dpi_resources/eu-cooperation-on-hta-2018/) - EUCOPE suggests a clear methodology and broader stakeholder involvements considers for the Commission's Regulation for a European HTA. - [Gene & Cell Therapy - Pioneering Access for Ground-Breaking Treatments (2018)](https://www.eucope.org/dpi_resources/gene-cell-therapy-pioneering-access-for-ground-breaking-treatments-2018/) - To make sure healthcare systems can assimilate such transformative innovations, EUCOPE calls for: Greater flexibility from HTA processes, innovative funding models and a proper implementation of the cross-border healthcare Directive. - [Artificial Intelligence in Health (2021)](https://www.eucope.org/dpi_resources/artificial-intelligence-in-health-2021/) - [The Future of Rare Disease Innovation in Europe](https://www.eucope.org/dpi_resources/the-future-of-rare-disease-innovation-in-europe/) ## Categories - [News](https://www.eucope.org/category/news/) - [Press Releases](https://www.eucope.org/category/press/) - [EUCOPE Resources](https://www.eucope.org/category/resources/) - [Events & Meetings](https://www.eucope.org/category/events_meetings/) - [Partnerships](https://www.eucope.org/category/partnerships/) - [Member Spotlight](https://www.eucope.org/category/member-spotlight/) - [Partnerships in Focus](https://www.eucope.org/category/partnerships-in-focus/) ## Tags - [Medical Devices](https://www.eucope.org/tag/medical-devices/) - [Regulatory](https://www.eucope.org/tag/regulatory/) - [Safety](https://www.eucope.org/tag/safety/) - [Medicines](https://www.eucope.org/tag/medicines/) - [Falsified](https://www.eucope.org/tag/falsified/) - [Supply](https://www.eucope.org/tag/supply/) - [Patients](https://www.eucope.org/tag/patients/) - [Events](https://www.eucope.org/tag/events/) - [MDR](https://www.eucope.org/tag/mdr/) - [IVDR](https://www.eucope.org/tag/ivdr/) - [Brexit](https://www.eucope.org/tag/brexit/) - [Digital](https://www.eucope.org/tag/digital/) - [FMD](https://www.eucope.org/tag/fmd/) - [Safety Features](https://www.eucope.org/tag/safety-features/) - [Rare Disease](https://www.eucope.org/tag/rare-disease/) - [Commission](https://www.eucope.org/tag/commission/) - [Health](https://www.eucope.org/tag/health/) - [Access](https://www.eucope.org/tag/access/) - [EMA](https://www.eucope.org/tag/ema/) - [Research](https://www.eucope.org/tag/research/) - [COVID19](https://www.eucope.org/tag/covid19/) - See here a digest of news or articles in relation to the COVID-19 crisis. For further information, please contact us at office@eucope.org. - [ATMPs](https://www.eucope.org/tag/atmps/) - [Publication](https://www.eucope.org/tag/publication/) - [AdvancedDxs](https://www.eucope.org/tag/advanced-diagnostics/) - [Paediatrics](https://www.eucope.org/tag/paediatrics/) - [OMP](https://www.eucope.org/tag/omp/) - [EHFG](https://www.eucope.org/tag/ehfg/) - [podcast](https://www.eucope.org/tag/podcast/) - [Members](https://www.eucope.org/tag/members/) - [innovation](https://www.eucope.org/tag/innovation/) - [HTA](https://www.eucope.org/tag/hta/) - [genomics](https://www.eucope.org/tag/genomics/) - [MEDTECH](https://www.eucope.org/tag/medtech/) - [HERA](https://www.eucope.org/tag/hera/) - [GDPR](https://www.eucope.org/tag/gdpr/) - [data act](https://www.eucope.org/tag/data-act/) - [EHDS](https://www.eucope.org/tag/ehds/) - [SoHO Regulation](https://www.eucope.org/tag/soho-regulation/) - [RWE](https://www.eucope.org/tag/rwe/) - [European Parliament](https://www.eucope.org/tag/european-parliament/) - [ENVI](https://www.eucope.org/tag/envi/) - [PharmaPackage](https://www.eucope.org/tag/pharmapackage/) - [biotech](https://www.eucope.org/tag/biotech/) - [European Commission](https://www.eucope.org/tag/european-commission/) - [shortages](https://www.eucope.org/tag/shortages/) - [EURORDIS](https://www.eucope.org/tag/eurordis/) - [EU Beating Cancer Plan](https://www.eucope.org/tag/eu-beating-cancer-plan/) - [Genomic Testing](https://www.eucope.org/tag/genomic-testing/) - [Joint Statement](https://www.eucope.org/tag/joint-statement/) - [EPSCO](https://www.eucope.org/tag/epsco/) - [EU Health](https://www.eucope.org/tag/eu-health/) - [competitiveness](https://www.eucope.org/tag/competitiveness/) - [pharma](https://www.eucope.org/tag/pharma/) - [EU Institutions](https://www.eucope.org/tag/eu-institutions/) - [clinical trial](https://www.eucope.org/tag/clinical-trial/) - [gene therapy](https://www.eucope.org/tag/gene-therapy/) - [EU competitiveness](https://www.eucope.org/tag/eu-competitiveness/) - [Life Science](https://www.eucope.org/tag/life-science/) - [RNA](https://www.eucope.org/tag/rna/) - [medicine shortages](https://www.eucope.org/tag/medicine-shortages/) - [World Health Assembly](https://www.eucope.org/tag/world-health-assembly/) - [IFPMA](https://www.eucope.org/tag/ifpma/) - [cancer](https://www.eucope.org/tag/cancer/) - [hematology](https://www.eucope.org/tag/hematology/) - [cell therapies](https://www.eucope.org/tag/cell-therapies/) - [antimicrobials](https://www.eucope.org/tag/antimicrobials/) - [AMR](https://www.eucope.org/tag/amr/) - [life sciences](https://www.eucope.org/tag/life-sciences/) - [report](https://www.eucope.org/tag/report/) - [eu](https://www.eucope.org/tag/eu/) - [legislation](https://www.eucope.org/tag/legislation/) - [gpl](https://www.eucope.org/tag/gpl/) - [clinical trials](https://www.eucope.org/tag/clinical-trials/) ## Document Types - [Working Group Meetings](https://www.eucope.org/memberdocs/working-group-meetings/) - [Members Mails](https://www.eucope.org/memberdocs/members-mails/) - [External Documents](https://www.eucope.org/memberdocs/external-documents/) ## Event Types - [Events](https://www.eucope.org/dpi_events_type/events/) - [Meetings](https://www.eucope.org/dpi_events_type/meetings/) ## Labels - [White Paper](https://www.eucope.org/dpi_resource_label/white-paper/) - [Position Paper](https://www.eucope.org/dpi_resource_label/position-paper/) - [Factsheet](https://www.eucope.org/dpi_resource_label/factsheet/) - [Joint Statement](https://www.eucope.org/dpi_resource_label/joint-statement/) - [Video](https://www.eucope.org/dpi_resource_label/video/) - [Event Report](https://www.eucope.org/dpi_resource_label/event-report/) - [Statement](https://www.eucope.org/dpi_resource_label/statement/) - [Podcast](https://www.eucope.org/dpi_resource_label/podcast/) - [Blog Post](https://www.eucope.org/dpi_resource_label/blog-post/) - [Policy Brief](https://www.eucope.org/dpi_resource_label/policy-brief/) - [Webinar](https://www.eucope.org/dpi_resource_label/webinar/) - [Press Release](https://www.eucope.org/dpi_resource_label/press-release/) - [Study](https://www.eucope.org/dpi_resource_label/study/) ## Topics - [Advanced Diagnostics](https://www.eucope.org/dpi_resource_type/advanced-diagnostics/) - Please find our main resources on Advanced Diagnostics below. - [Advanced Therapy Medicinal Products (ATMPs)](https://www.eucope.org/dpi_resource_type/advanced-therapy-medicinal-products-atmps/) - Please find our main resources on Advanced Therapy Medicinal Products (ATMPs) below. - [Brexit](https://www.eucope.org/dpi_resource_type/brexit/) - Please find our resources related to Brexit below. - [Digital Health](https://www.eucope.org/dpi_resource_type/digital-health/) - Please find all of our resources related to Digital Health below. - [Intellectual Property & Incentives](https://www.eucope.org/dpi_resource_type/intellectual-property-incentives/) - Please find our main resources related to IP and Incentives below. - [Medical Devices & IVDs](https://www.eucope.org/dpi_resource_type/medical-devices-ivds/) - Please find our main resources related to Medical Devices below. - [Orphan Medicinal Products (OMPs) & Paediatrics](https://www.eucope.org/dpi_resource_type/orphan-medicinal-products/) - Please find our main resources on Orphan Medicinal Products (OMPs) and Paediatrics below. You may also visit our Rare Disease Hub. - [Pricing & Reimbursement / Market Access](https://www.eucope.org/dpi_resource_type/pricing-reimbursement-market-access/) - Please find our main resources related to Pricing & Reimbursement as well as Market Access below. - [Regulatory Developments](https://www.eucope.org/dpi_resource_type/regulatory-developments/) - Please find our main resources related to Regulatory Developments below. - [Health Technology Assessment (HTA)](https://www.eucope.org/dpi_resource_type/health-technology-assessment-hta/) - Please find our main resources related to HTA below. - [EU Pharmaceutical Strategy](https://www.eucope.org/dpi_resource_type/eu-pharmaceutical-strategy/) - Please find our main resources related to the EU Pharmaceutical Strategy below. - [Economic Off Label Use and Compounding](https://www.eucope.org/dpi_resource_type/economic-off-label-use-and-compounding/) - Please find our main resources on Economic Off Label Use and Compounding below. - [Health Emergency, Preparedness & Response Authority (HERA)](https://www.eucope.org/dpi_resource_type/health-emergency-preparedness-response-authority-hera/) - Please find our main resources related to HERA and public health threats below. - [Life Science Lectures (LSL)](https://www.eucope.org/dpi_resource_type/life-science-lectures/) - Please find our webinar series episodes on healthcare and life sciences below. - [Competitiveness & Trade](https://www.eucope.org/dpi_resource_type/competitiveness-trade/)