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ACT EU and the Future of Clinical Research in Europe
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
The session will focus on the Accelerating clinical trials in the EU (ACT EU) initiative, which aims to transform clinical trials in the European Union. The keynote speech will outline the European Medicines Regulatory Network’s vision for clinical research in the region, reflecting on the progress towards better, faster and optimised clinical trials and highlighting key milestones under ACT EU. A panel of stakeholder representatives will exchange views on the main challenges and opportunities for improving the clinical trial environment in Europe.
Speaker(s)
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
Introduction
Nikos Dedes
Representative, European AIDS Treatment Group (EATG), Greece
Patient Representative
Stéphanie Kromar
Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Academia Representative
Kasper Bendix Johnsen
Head of Section, Danish National Center For Ethics, Denmark
Ethics Representative
Ditte Zerlang Andersen, PHD, MSC
Senior Strategy Project Lead, Danish Medicines Agency (DKMA), Denmark
Expert on Methodologies Guidance
Laurence O'Dwyer, RPH
Scientific Affairs Manager, Health Products Regulatory Authority, Ireland
Expert on Scientific Advice Coordination/SNSA
Stefan Schwoch, PHD, RPH
VP Global Regulatory Affairs EMEA, Eli Lilly and Company Limited, United Kingdom
Industry Representative
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