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
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
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
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
On Rare Diseases Day, EUCOPE is delighted to host an interview with Laurence Woollard, patient expert and rare disease advocate, to discuss with him the importance of an engaged community and the opportunities and challenges new treatments can bring. See Laurence’s Q&A on our blog.
As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework.
The Czech Ministry of Health recently announced that the Public Health Insurance Act 48/1997, which regulates the scope and conditions under which health services are covered as well as their pricing and reimbursement, would be amended. The foreseen amendments, expected to enter into force in… read more
Earlier this month, the Maltese Deputy Prime Minister and Minister for Health, Mr Chris Fearne, met with EUCOPE to discuss issues pertaining to transparency and access to medicines. This meeting took place against the background of the ongoing activities of the Valetta Declaration – which,… read more
EUCOPE, together with 16 associations representing patients, healthcare professionals and the pharmaceutical and devices industry have joined efforts in supporting the event “Brexit: the European Parliament’s role in prioritising patients, public health and health security across Europe”, to be held on September the 12th in… read more
The European Commission just published a FAQ document on the new Unique Device Identification (UDI) system, as introduced by the two new Regulations on Medical Devices (2017/745) and In Vitro Diagnostics Devices (2017/746). The document spells out the objectives of this new system, namely to… read more