News - May 24, 2019
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… read more
News - May 22, 2019
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… read more
Events & Meetings / News - May 7, 2019
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… read more
News - April 26, 2019
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… read more
News - April 16, 2019
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… read more
News - April 1, 2019
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… read more
News - March 27, 2019
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… read more
News - March 7, 2019
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… read more
News - February 28, 2019
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… read more
News - February 13, 2019
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… read more
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