News - April 21, 2020
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… read more
News - April 17, 2020
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… read more
News - April 14, 2020
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… read more
News - April 8, 2020
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… read more
News - April 8, 2020
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… read more
EUCOPE Resources / News - April 6, 2020
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… read more
News - April 3, 2020
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,… read more
News - March 26, 2020
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,… read more
News - March 19, 2020
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… read more
News / Press Releases - March 10, 2020
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… read more
