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Session 4, Track A: Current and Emerging Regulatory Uses of Real-World Evidence
Session Chair(s)
My (may) Dang, MBA
Director, Regulatory Affairs, Cencora, Canada
Brenda Gryfe, MSc
Regulatory Consultant, Brenda Gryfe Regulatory Consulting, 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)
Andrew Raven, MSc
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB, Health Canada, Canada
Current and Emerging Regulatory Uses of Real-World Evidence
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
US FDA and Real-World Evidence
Christopher Pettengell, MD, MSc
Chief Medical Officer, Pentavere, Canada
Current and Emerging Regulatory Uses of Real-World Evidence