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The Implications Of The New EU HTA Regulation For Companies

Joint Clinical Assessments Will Become A Key Part Of The New Environment Regulation (EU) 2021/2282 on health technology assessment (HTA) is now in force and will bring important and wide-reaching changes that pharmaceutical companies need to understand. Arguably the most important implication of the regulation…

https://www.eucope.org/the-implications-of-the-new-eu-hta-regulation-for-companies/

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…

https://www.eucope.org/events/european-hta-what-have-we-learned-what-lies-ahead/

Joint pharmaceutical industry statement on the Commission’s proposal for a Regulation on health technology assessment (HTA)

…particularly important for the competitiveness of small-scale biopharmaceutical companies active in Europe. For the future system to work, we agree it is crucial that the joint clinical assessment replaces the equivalent step in the national HTA process. However as experienced in EUnetHTA, in a purely…

https://www.eucope.org/joint-pharmaceutical-industry-statement-on-the-commissions-proposal-for-a-regulation-on-health-technology-assessment-hta/

EVENT RECAP – Life Science Lectures: Episode Four "Leveraging early advice opportunities in EU HTA"

…new EU health technology assessment (HTA), which will be mandatory for all new oncology products and ATMPs from 12 January 2025. EUCOPE experts went over the opportunities for receiving joint scientific advice from EMA and HTA bodies in parallel in the interim period leading up…

https://www.eucope.org/event-recap-life-science-lectures-episode-four-leveraging-early-advice-opportunities-in-eu-hta/

Preparing for EU HTA Joint Clinical Assessments and Joint Scientific Consultations – Practical information to navigate the new procedures

…the HTA Coordination Group. Participants are invited to ask questions and share their views through a dynamic Q&A session. Don’t miss this chance to prepare for the new market launch requirements in Europe. Register now! Find out ore about EUCOPE activities on EU HTA here…

https://www.eucope.org/events/preparing-for-eu-hta-joint-clinical-assessments-and-joint-scientific-consultations-practical-information-to-navigate-the-new-procedures/

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…

https://www.eucope.org/press-release-eu-hta-proposal-council-on-the-verge-of-a-compromise/

RWE4Decisions "Supporting HTA/Payer decision-making: Spotlight on health data initiatives in Germany"

HTA/Payer decision-making. This is the second public webinar to update on how countries are developing their data environments in a way that could be useful for HTA bodies and Payers, to support additional data collection. EUCOPE’s Alexander Natz will take part in the moderated discussion….

https://www.eucope.org/events/rwe4decisions-supporting-hta-payer-decision-making-spotlight-on-health-data-initiatives-in-germany/

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…

https://www.eucope.org/eucope-statement-on-council-hta-compromise-march-2021/

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, and how prepared they are for it. Remap is eager to get feedback from small and mid-sized companies as part of the…

https://www.eucope.org/remap-consulting-survey-on-the-new-eu-hta-regulation/

The new EU-wide health technology assessment for innovative drugs

…biotech company Antje Behring, Department Head Pharmaceuticals, G-BA (German Federal Joint Committee, Germany’s HTA Agency): The planned Europe-wide HTA harmonization from the perspective of a European HTA-Agency. Norbert Gerbsch, Department Head Public Affairs, IGES Institut (moderator): Integration of the harmonized EU-HTA procedure into the clinical…

https://www.eucope.org/events/the-new-eu-wide-health-technology-assessment-for-innovative-drugs/