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Session 8, Track C: Apply Real-World Evidence in Canada - Design, Regulatory Expectations, and Safety Applications
Session Chair(s)
Ricardo Pasquel Cook, MD
Safety Team Lead, Pfizer Inc., Canada
Riti Singh, PharmD, MBA
National Director - Scientific Affairs, Regulatory and Quality (SARQ), Bayshore Healthcare (Bayshore Specialty Rx Ltd.), Canada
This session will explore how real-world evidence (RWE) is generated and applied across the Canadian lifecycle, from addressing pre-market evidence gaps to informing post-market safety decision-making. Speakers will cover foundational RWE study designs, key methodological challenges (e.g., bias, confounding, and data quality), and the Canadian data and regulatory landscape, including HTA perspectives. The session will also provide practical insights into the application of ICH M14 principles for planning, analyzing, and reporting non-interventional studies. Through case examples and regulatory perspectives, participants will gain a clear understanding of how to design and interpret RWE studies that meet both regulatory and payer expectations.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe key RWE study designs and common methodological challenges in non-interventional studies
- Apply ICH M14 principles to the design, analysis, and reporting of RWE for safety assessments
- Evaluate how RWE is used in Canadian regulatory and HTA decision-making across the product lifecycle
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