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Hilton Lac-Leamy

14 nov 2024 7:30 a.m. - 15 nov 2024 4:10 p.m.

3 Boulevard du Casino, Gatineau, QC J8Y 6X4, Canada

Canada Annual Meeting

The Canada Annual Meeting offers three tracks, Regulatory, Clinical, Safety and Pharmacovigilance!

Session 4, Track A: Current and Emerging Regulatory Uses of Real-World Evidence

Session Chair(s)

My  Dang, MBA

My Dang, MBA

Director/Consultant, Regulatory Affairs

Cencora, Canada

Brenda  Gryfe, MSc

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)

Andrew  Raven, MSc

Current and Emerging Regulatory Uses of Real-World Evidence

Andrew Raven, MSc

Health Canada, Canada

Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB

John  Concato, MD, MPH, MS

US FDA and Real-World Evidence

John Concato, MD, MPH, MS

FDA, United States

Associate Director for Real-World Evidence Analytics, OMP, CDER

Christopher  Pettengell, MD, MSc

Current and Emerging Regulatory Uses of Real-World Evidence

Christopher Pettengell, MD, MSc

Pentavere, Canada

Chief Medical Officer

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