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Session 1: Requirements and Opportunities for Innovation in Clinical Trials in Europe: Navigating the Legislation Landscape
Session Chair(s)
Elke Stahl, PhD
Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
AGES, Austria
Session will inform about the legislation landscape with impact on Clinical Trials with focus on experiences on CTR implementation and outlook to further environment opportunities.
Speaker(s)
How Can The Clinical Research Environment in Europe be Improved?
Susan Bhatti, PhD
Merck BV, Netherlands
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs
Industry Feedback on a Successful Adoption of EU CTR and Challenges and Opportunities in Landscape
Martin O'Kane
Novartis Pharmaceuticals, United Kingdom
Regional Head RA EU Policy & Liaison
Streamlining regulations in clinical trials: new opportunities and, challenges
Marianne Lunzer, DrMed
AGES, Austria
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
Clinical Trials in Europe: Opportunities for changes on the way
Isabelle Clamou
European Commission, Belgium
Policy Officer, DG SANTE Unit D2
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