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Session 6 Track B: Towards a Structured, Criteria-Based, and Transparent Regulatory Decision-Making: A Brainstorming Session
Session Chair(s)
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada, Canada
Evidence-based decision-making is common to both healthcare and regulatory decisions. However, the decision-making process and criteria may not be clear to the relevant stakeholders. This session aims to bring together pre- and post-market regulatory expertise and academic expertise in Evidence-based medicine in an exchange of ideas to explore the potential for furthering regulatory decision-making methodologies.
Speaker(s)
Hydrochlorothiazide and the Risk of Non-melanoma Skin Cancer: a Signal Assessment Using the GRADE Approach
Mohammed Toseef Ansari, MD, MS, MSc
Health Canada/Marketed Health Products Directorate, Canada
Senior Scientific Evaluator
Speaker
Jan Brozek, MD, PhD
McMaster University, Canada
Associate Professor, Health Research Methods, Evidence, and Impact
Speaker
Jeremy Jokinen, PhD, MS
Argenx, United States
Vice President and Head Global Patient Safety
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