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Delta Hotels Ottawa City Centre

Oct 18, 2022 1:00 PM - Oct 19, 2022 9:10 PM

101 Lyon Street North, Ottawa, ON K1R 5T9, Canada

Canada Annual Meeting

Session 6, Tracks A, B: Real-World Data (RWD) and Real-World Evidence (RWE) in Regulatory Decision Making

Session Chair(s)

Marcia  Sam

Marcia Sam

Regulatory Affairs Strategy and Policy Manager

Hoffmann-La Roche Canada Limited, Canada

Lorella  Garofalo, PhD

Lorella Garofalo, PhD

Head of Regulatory Sciences

Pfizer Canada, 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


Kimberly  Smith, MD, MS

U.S. FDA and Real-World Evidence: Kimberly Smith, MD, MS

Real-World Evidence Analytics Team, Office of Medical Policy, CDER

FDA, United States

Karma M. Rabon-Stith, PhD, MBA, PMP

Understanding the Evolution of Real-World Data / 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

Catherine  Njue, PhD

Real-World Data (RWD) and Real-World Evidence (RWE) in Decision Making: A Regulatory Perspective: Catherine Njue, PhD

Manager, Office of Biostatistics

Health Canada , Canada

Donna  Janzen

How does Canada compare in Leveraging RWE in Regulatory Decision Making?: Donna Janzen

Director, Regulatory Strategy & Policy

Hoffmann-La Roche, Ltd., Canada

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