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Session 4, Track A: Current and Emerging Regulatory Uses of Real-World Evidence
Session Chair(s)
My Dang, MBA
Director/Consultant, Regulatory Affairs
Cencora, Canada
Brenda Gryfe, MSc
Regulatory Consultant
Flying Moose Technologies , Canada
Stakeholders ranging from academics, industry, regulators, and health care providers have long recognized the opportunity of using real-world data (RWD) to evaluate the benefits and risks of medical products. Leveraging fit-for-purpose real world evidence (RWE) to support regulatory decision-making continues to gain ground. This session will focus on the perceived gaps in the evidence generation process and potential opportunities for future development and harmonization of RWE.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the regulatory limitations of RWE
- Predict future directions to improve RWE use in regulatory decision-making
- Highlight examples of successful regulatory decisions that were supported by RWE
Speaker(s)
Current and Emerging Regulatory Uses of Real-World Evidence
Andrew Raven, MSc
Health Canada, Canada
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
US FDA and Real-World Evidence
John Concato, MD, MPH, MS
FDA, United States
Associate Director for Real-World Evidence Analytics, OMP, CDER
Current and Emerging Regulatory Uses of Real-World Evidence
Christopher Pettengell, MD, MSc
Pentavere, Canada
Chief Medical Officer