News / Press Releases - April 26, 2023
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… read more
Member Spotlight / News - April 24, 2023
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 March, we spoke with Fabien Roy, Partner, Hogan Lovells Life Sciences practice. Fabien Roy is a partner at Hogan… read more
Events & Meetings / News / Press Releases - April 18, 2023
In November 2020, the European Commission adopted the EU Pharmaceutical Strategy, aimed at creating a future-proof regulatory framework and at supporting the industry in promoting research and technologies that reach patients in order to fulfil their therapeutic needs while addressing market failures. As part of… read more
News - March 14, 2023
On 7 March, 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 and paves the way for the formal signature of the legislative text, which is scheduled for… read more
EUCOPE Resources / News - February 22, 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… read more
Member Spotlight / News - February 22, 2023
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… read more
News - January 23, 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… read more
News - November 26, 2022
Art. 28 para. 5 HCR is no longer applicable due to an unlawful act of suspension by the European Commission The former president judge at the German Constitutional Court Professor Dr. Udo Di Fabio stated in a legal opinion that the suspension in the assessment… read more
EUCOPE Resources / News - September 20, 2022
Sounds of Science Podcast – Episode 8 Ensuring a Robust European Health Data Space (EHDS) On 3 May 2022, the European Commission published the proposal for a regulation introducing the European Health Data Space (or EHDS). The proposal aims to enable better exchange and access… read more
EUCOPE Resources / News - July 19, 2022
Sounds of Science Podcast – Episode 7 Unmet Medical Needs (UMN): Towards a new understanding with a focus on underserved areas The topic of unmet medical needs (UMN) is quite high up on the agenda in European health policy these days. Recent literature has identified… read more
