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Session 1: Regulatory Frameworks for Real World Evidence
Session Chair(s)
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
FDA, United States
This session will be an update on FDA’s RWE program including a review of top priorities, program initiatives, and demonstration programs and updates from EMA on their RWE initiatives.
Learning Objective : At the conclusion of this session, participants should be able to:- Define the elements of FDA’s RWE framework
- Describe two demonstration projects and their relevance to the FDA’s program
- Discuss current harmonization among regulatory approaches
Speaker(s)
Speaker
Jacqueline A. Corrigan-Curay, JD, MD
FDA, United States
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making
Andrew Raven, MSc
Health Canada, Canada
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
Use of Real World Evidence for Regulatory Decision Making: Perspectives from the European Medicines Agency (Remote Presentation)
Xavier Kurz, MD, PhD, MSc
European Medicines Agency, Netherlands
Head of Data Analytics Workstream
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