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
EUCOPE Resources / News - April 11, 2023
Sounds of Science Podcast – Episode 15 MDR/IVDR: Recent changes and their implications for EU medical device companies and patients The EU’s Medical Device Regulation (MDR) came into full effect on 26 May 2021 and was followed by the In Vitro Diagnostic Device Regulation (IVDR)… read more
News - April 5, 2023
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… read more
Member Spotlight / News - March 31, 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 Adam Plich, Founder and CEO of Avanzanite Bioscience B.V. Adam Andrzej Plich is the… read more
News - March 29, 2023
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… read more
News / Partnerships / Press Releases - March 24, 2023
On March 22, in a workshop in the European Parliament hosted by MEP Weiss, the OD Expert Group presented its Policy Proposals for the revision of the OMP Regulation. Thanks to everyone who participated in the event, whether in-person or remotely . The OD Expert… read more
News - March 17, 2023
The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)). As of… read more
EUCOPE Resources / News - March 17, 2023
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… 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
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