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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)
Complex, risk-adapted, low-interventional trials – CA perspective and highlights from workshop on complex clinical trials in Rome 2018
Ditte Zerlang Andersen, PHD, MSC
Danish Medicines Agency (DKMA), Denmark
Senior Strategy Project Lead
Sponsors’ Perspective
Christine Fletcher, MSC
GlaxoSmithKline, United Kingdom
VP/Head, Speciality and Primary Care Statistics
Louise Brown
UCL, Institute of Clinical Trials & Methodology, United Kingdom
Senior Statistician - Clinical Trials Unit