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Session 3, Tracks B & C: Pre- and Post-marketing Surveillance: Best Practices
Session Chair(s)
Nadiya Jirova, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
Health Canada, Canada
Myriam Salem, MSc
Good Pharmacovigilance Practices National Coordinator
Health Canada, Canada
In this session health Canada will provide practical guidance for several areas of pre- and post-market surveillance. This session will provide practical advice on reporting Adverse Drug Reactions (ADRs) from various sources. The session will kick off with the Canada Vigilance is Health Canda’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada. A second presentation will give an overview of Health Canada's Vigilance framework for cannabis and cannabis products and reporting ADRs to the Canada Vigilance Program. This session will conclude with two presentations from the pre-market and post-market inspectorate program, the Good Clinical Practices Inspection program and the Good Pharmacovigilance Practices (GVP) Inspection program to address common industry questions to address common industry questions including tips on how to prepare for GVP inspections.
Learning Objective : - Identify cases that must be reported to Health Canada under Food and Drug Regulations
- Identify cases that must be reported under the Cannabis Regulations
- Describe Inspectorate’s expectations during Health Canada GCP inspections
- Describe Inspectorate’s expectations during Health Canada GVP inspections
Speaker(s)
Best Practices on Reporting Adverse Reactions from Various Sources
Silas Da Graça, MSc
Health Canada, Canada
A/Manager, Adverse Reaction Monitoring and Information Section
Health Canada's Vigilance Framework for Cannabis and Cannabis Products
Safia Hassan
Health Canada, Canada
Scientific Evaluator
Health Canada’s Clinical Trial Compliance Program
Hocine Abid, MD, MBA
Health Canada, Canada
National Manager, Regulatory Operations and Enforcement Branch
GVP Inspection Trends, Ongoing Initiatives, and Best Practices
Fadi Sader, PhD
Health Canada, Canada
Regional Regulatory Compliance and Enforcement Officer