On 25th January 2023, under the upcoming Swedish Presidency of the Council of the EU, key members of the European Parliament, supported by Re-Imagine Europa, the Society for Clinical Data Management (SCDM), and Viedoc, will organise an event on the “Future of Clinical Trials and Health Data in Europe”.
The EU Clinical Trial Regulation became effective in early 2022 and it is now in the 3-year transition period in which the former system under the EU Clinical Trials Directive and the new system under the EU Clinical Trial Regulation are available in parallel.
The aim of the event is to discuss lessons learned from different stakeholders on the ongoing application of the EU Clinical Trial Regulation, taking also into consideration the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU), developed by the European Commission, the Heads of Medicines Agencies (HMA) and the European Medicine Agency (EMA).
The event will bring together leading data and clinical operations representatives from biotech, pharma, and clinical research organisations to inform and openly discuss these issues with representatives from European institutions and other key stakeholders.
Among the speakers are Andrey Kovatchev, Member of the European Parliament, Tomislav Slov, Member of the European Parliament, Andrzej Rys, Principal Scientific Adviser of the Directorate-General for Health and Food Safety (DG SANTE) of the European Commission, Björn Eriksson, Director-General of the Swedish Medical Products Agency (MPA), Marco Greco, President of the European Patients’ Forum, Jonathan R. Andrus, Societal regulatory liaison at the Society for Clinical Data Management, Vytenis Andriukaitis, Former European Commissioner for Health and Food Safety and Chair of AP4HE, Emer Cooke, Executive Director of the European Medicines Agency (EMA), Nils Torvalds, Member of the European Parliament, and Mats Klaar, CEO at Viedoc. The event will be moderated by Erika Staël von Holstein, Chief Executive of Re-Imagine Europa.
You can find details about the different sessions in the attached event agenda.