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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)
Susan Bhatti, PHD
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs, Merck BV, Netherlands
How Can The Clinical Research Environment in Europe be Improved?
Martin O'Kane
Regional Head RA EU Policy & Liaison, Novartis Pharmaceuticals, United Kingdom
Industry Feedback on a Successful Adoption of EU CTR and Challenges and Opportunities in Landscape
Marianne Lunzer, DrMed
Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria
Streamlining regulations in clinical trials: new opportunities and, challenges
Isabelle Clamou
Policy Officer, DG SANTE Unit D2, European Commission, Belgium
Clinical Trials in Europe: Opportunities for changes on the way