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Session 7, Track C: Post-Market Drug Evaluation in Canada: The Role of Canada’s Drug Agency PMDE Program
Session Chair(s)
Yulia Vasianovich, PhD, RAC
Scientific Evaluator, Marketed Health Products Directorate
Health Canada, Canada
Randy Levitt, PhD
Director, Pharmacovigilance, Medical Information and Patient Support
Knight Therapeutics Inc., Canada
The Post-Market Drug Evaluation (PMDE) Program, launched by Canada’s Drug Agency (CDA) in 2022, provides timely, evidence-based responses to questions from federal, provincial, and territorial decision-makers about the safety and effectiveness of approved drugs. Supported by a national expert network known as CoLab, the program delivers real-world insights about post-market drug safety and effectiveness. This session will feature Health Canada on the need for post-market evidence in regulatory decision-making, an overview of CDA’s PMDE Program and its impact, and examples of the work of one of CoLab's core network partners, the Canadian Network for Observational Drug Effect Studies (CNODES).
- Health Canada’s Key Collaborations in Real-World Evidence (RWE) Use for Post-market Drug Safety Evaluation
Celline Brasil, Health Canada - The Role of the PMDE Program and its National Collaborative Network
Tarry Ahuja, Canada Drug Agency - Canadian Network for Observational Drug Effect Studies (CNODES)
Michael Paterson, Institute for Clinical Evaluative Sciences
Learning Objective : <
At the conclusion of this session, participants should be able to:
- Identify Health Canada domestic and international collaborations and key initiatives in harmonizing and using real-world data (RWD) for post-market drug evaluation
- Understand the structure, goals and the impact of CDA’s PMDE Program and the CoLab Network
- Recognize the role of stakeholder input—patients, clinicians, and industry—in shaping PMDE activities
Speaker(s)
Health Canada’s Key Collaborations in Real-World Evidence (RWE) Use for Post-market Drug Safety Evaluation
Celline Brasil, PhD, MPH
Health Canada, Canada
Senior Epidemiologist
The Role of the PMDE Program and its National Collaborative Network
Tarry Ahuja, DrSc, MSc
Canada's Drug Agency, Canada
Director, Post Market Drug Evaluation (PMDE)
Canadian Network for Observational Drug Effect Studies (CNODES)
Michael Paterson, MSc
Institute For Clinical Evaluative Sciences (ICES), Canada
Scientist and Research Program Lead
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