EUCOPE Resources / News - May 6, 2020
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury, bringing with them the promise of treatment of severe, disabling or life-limiting conditions but also… read more
News - May 5, 2020
The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every… read more
News - May 4, 2020
On 27 and 28 May, EUCOPE and Drug Information Association (DIA) jointly organise an online workshop on ATMPs and Innovative Gene and Cell Therapies. The event is a unique opportunity to hear directly from the Industry and Regulatory representatives about the challenges, opportunities and political… read more
News - April 28, 2020
The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical implications concerning the need for… read more
News - April 28, 2020
On 3 April, the European Commission adopted a proposal to postpone by one year the application of the Medical Devices Regulation (MDR). Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April. The amending Regulation 2020/561… 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
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 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
