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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)
Introduction
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Patient Representative
Nikos Dedes
European AIDS Treatment Group (EATG), Greece
Representative
Academia Representative
Stéphanie Kromar
European Organisation for Research and Treatment of Cancer (EORTC) , Belgium
Senior Regulatory Affairs Manager
Ethics Representative
Kasper Bendix Johnsen
Danish National Center For Ethics, Denmark
Head of Section
Expert on Methodologies Guidance
Ditte Zerlang Andersen, PhD, MSc
Danish Medicines Agency (DKMA), Denmark
Senior EU Project Lead
Expert on Scientific Advice Coordination/SNSA
Laurence O'Dwyer, RPh
Health Products Regulatory Authority, Ireland
Scientific Affairs Manager
Industry Representative
Stefan Schwoch, PhD, RPh
Eli Lilly and Company Limited, United Kingdom
VP Global Regulatory Affairs – International
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