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 28, 2020
The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The… read more
News - April 22, 2020
EUCOPE, together with experts from Ministries, HTA agencies and pharmaceutical companies, will take part in the next FORUM Event in Berlin on 9 July 2020. The seminar will give the opportunity to discuss, inter alia, the priorities of the German Presidency of the EU on… read more
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
