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Session 3: Complex Clinical Trials/Risk-Adapted Trials/Low-Interventional Trials
Session Chair(s)
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
This session discusses challenges that are raised by the existing regulatory framework and the implementation of CT Regulation for conducting such trials and what are the updates of the workshop.
Speaker(s)
Ditte Zerlang Andersen, PHD, MSC
Senior Strategy Project Lead, Danish Medicines Agency (DKMA), Denmark
Complex, risk-adapted, low-interventional trials – CA perspective and highlights from workshop on complex clinical trials in Rome 2018
Christine Fletcher, MSC
VP/Head, Speciality and Primary Care Statistics, GlaxoSmithKline, United Kingdom
Sponsors’ Perspective
Louise Brown
Senior Statistician - Clinical Trials Unit , UCL, Institute of Clinical Trials & Methodology, United Kingdom
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