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Session 6, Tracks A, B: Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decision Making
Session Chair(s)
Marcia Sam
Senior Manager, Regulatory Affairs, Regeneron Canada Company, Canada
Lorella Garofalo, PHD
Head of Regulatory Sciences, Pfizer Canada ULC, Canada
The use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision making continues to evolve as interest in leveraging RWD and RWE throughout the drug lifecycle grows. This session will provide an overview of key considerations, challenges and best practices in the generation and assessment of RWD and RWE for pre-approval regulatory decision making. Use cases for RWE in regulatory decision making will also be reviewed.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain how RWD and RWE can be leveraged to support regulatory decision making
- Discuss challenges and opportunities from current use of RWE to inform drug development
- Describe key considerations for the use of RWE by regulators
Speaker(s)
Kimberly Smith, MD, MS
Real-World Evidence Analytics Team, Office of Medical Policy, CDER, FDA, United States
U.S. FDA and Real-World Evidence
Karma M. Rabon-Stith, PHD, MBA, PMP
Global Oncology Real World Evidence CoE Lead // Senior Director Team Lead, Pfizer Inc., United States
Understanding the Evolution of Real-World Data / Real-World Evidence
Catherine Njue, PHD
Manager, Office of Biostatistics, Health Canada , Canada
Real-World Data (RWD) and Real-World Evidence (RWE) in Decision Making: A Regulatory Perspective
Donna Janzen
Director, Regulatory Strategy & Policy, Hoffmann-La Roche, Ltd., Canada
How does Canada compare in Leveraging RWE in Regulatory Decision Making?
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