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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 P. Stein, MD
Director, Office of New Drugs, CDER
FDA, 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
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Complex Innovative Designs – An EU Overview
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
The Clinical Trials Coordination Group - CTCG
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
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