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Session 8: Regulatory Landscape of Innovative Trial Designs
Session Chair(s)
Dionne Price, PHD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Peter Stein, MD
Consultant, Peter Stein Consulting, LLC, United States
Innovative designs and analyses have the potential to improve trial efficiency while reliably answering scientific questions of interest in the evolving landscape of drug development. Global regulatory authorities have initiated multiple efforts that seek to advance the adoption of innovative designs and methods. This session will provide an overview of initiatives across regulatory bodies and discuss future challenges and opportunities.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss emerging challenges in drug development and the regulatory landscape that might be addressed with novel approaches
- Describe initiatives across regulatory authorities aimed at enhancing drug development efficiency
- Discuss future challenges and opportunities in the adoption of innovative designs and methods
Speaker(s)
Speaker
Consultant, Peter Stein Consulting, LLC, United States
Complex Innovative Designs – An EU Overview
Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
The Clinical Trials Coordination Group - CTCG
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
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