The European institutions have set-out a very ambitious agenda to create a more innovative, transparent and competitive ecosystem for clinical trials and health data in Europe. At Viedoc, we believe in the importance of continuing to organize such events as a way of giving back to the life sciences and data management community in a more meaningful way.
The meeting aimed to discuss lessons learned from different stakeholders in the nearly one-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 both in effect. The regulation, which became effective in early 2022, seeks to establish high standards of public transparency and safety for clinical trial participants and make the EU an attractive environment for conducting large-scale clinical research.
The event also addressed the 2022-2026 work plan of the Accelerating Clinical Trials in the EU (ACT EU) initiative, published by the European Commission, Heads of Medicines Agencies, and European Medicines Agency in August. The workplan is structured around ten priority actions and is based on the recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical Strategy for Europe.
Leading representatives from biotech, pharmaceutical, and clinical research organizations, as well as key stakeholders from across the European healthcare sector, attended the event, which was moderated by Erika Stael von Holstein, CEO of Re-Imagine Europa. The program included a welcome address by Tomislav Sokol, Member of the European Parliament, and a keynote presentation by Dr. Andrzej Rys, Deputy Director General of the European Commission's Directorate-General for Health and Food Safety, and several other presentatons from prominent figures in the field.
The event was a valuable opportunity for attendees to stay informed and openly discuss emerging regulatory changes and future challenges facing clinical trials. The event ended with a closing address by Nils Torvalds, Member of the European Parliament.
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"The system is incredibly robust and is very user friendly, both to sponsor level satff, as well as site staff who remotely enter data."