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Session 4 - Track A: Unique Regulatory Requirements in Canada
Session Chair(s)
Rocelyn DelCarmen
Director, Regulatory Affairs and Quality Assurance
Astrazeneca Canada Inc., Canada
Harmonization efforts have streamlined many regulatory requirements across the globe. There remains a few areas in the regulatory regime where Canadian requirements differ from other regions. During this session Health Canada and Industry speakers will review these areas of differentiation with a discussion of why the regime exists, and how stakeholders “act locally” to address it.
Speaker(s)
Impact of Canadian Specific Requirements for CRFs
Samar Darwish, MBA, MSc
Boehringer Ingelheim, Canada
Director, Drug Regulatory Affairs
Health Canada Regulations –The Nuts and Bolts: Importation & Release of Drug Products
David Lessard
Pfizer Canada Inc., Canada
Director of Quality and Compliance
Bioequivalence – Health Canada’s Perspective
Paul Wielowieyski
Health Canada, Canada
Acting Manager, Division of Biopharmaceutics Evaluation
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