This course aims to give you an understanding of the pharmacovigilance regulations and safety guidelines within Canada compared to US and EU legislations and guidelines.
Canadian legislation, Canada Regulatory Agency, Health Canada, Gazette, Notice of Compliance (NOC) Database, Special Access Program, Canada Vigilance Regional Offices, National System for Incident Reporting (NSIR), Bill C-17, Vanessa's law
LEARNING OUTCOMES
This course provides you with an overview of the Canadian pharmacovigilance practices and requirements for medicines, with a specific highlight on:
Pre-approval and post-approval
Focus on ADR Reporting for both Industry & Healthcare Institutions
Bill C-17: Protecting Canadians from Unsafe Drugs Act “Vanessa’s Law"
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