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Session 7, Track C: From Signal to Action -Managing Safety Risks in Self-Care Products Without Perfect Data
Session Chair(s)
Mei Lam, BSN, RN
Associate Director Consumer Safety Regions Americas, Haleon, Canada
Liliana Di Stabile, MD
Safety Physician, Knight Therapeutics Inc., Canada
This session explores how safety decisions are made for non-prescription and self-care products when data are incomplete or uncertain, integrating regulatory and industry perspectives. Drawing on real-world examples, Health Canada speakers will discuss how signals are identified, assessed, and translated into action, including balancing precaution with continuous monitoring, evidence thresholds, and regulatory judgment, while an industry speaker will share practical considerations and challenges in a model that was created for prescription products. The session will also highlight the growing use of non-traditional data sources and evolving regulatory tools to support post-market oversight. Attendees will gain practical insight into how uncertainty is navigated and managed across both regulators and industry in modern pharmacovigilance decision-making.
Learning Objective : - Explain how Health Canada identifies, assesses, and acts on safety signals for self-care products in the context of data uncertainty
- Compare Health Canada’s regulatory approach with industry practices, including application of precaution, evidence thresholds, and lifecycle monitoring
- Assess how Health Canada leverages emerging data sources and regulatory tools to strengthen post-market safety oversight and decision-making
Speaker(s)
Speaker
Laurie Chapman, PhD, MSc
Senior Scientific Evaluator, Health Canada, Canada
Signal Management for Cannabis and Cannabis Products
Safia Hassan
Senior Regulatory Affairs Officer, Health Canada, Canada
Speaker
Christopher Gravel, PhD
Associate Professor, University of Ottawa (School of Epidemiology and Public Health), Canada
Speaker
Representative Invited
MSc Epidemiology candidate / Research Assistant, University of Ottawa, Canada
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