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Session 6, Track C: Good Pharmacovigilance Practices Inspection Readiness
Session Chair(s)
Myriam Salem, MSc
Good Pharmacovigilance Practices National Coordinator
Health Canada, Canada
Agnes Jankowicz, MS
Vice President, Pharmacovigilance
Veristat, Canada
Nadiya Jirova, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
Health Canada, Canada
The Good Pharmacovigilance Practices (GVP) Inspection program at health Canada is intended to verify that health product manufacturers meet the requirements of the Food and Drug Regulations pertaining to adverse drug reaction (ADR) reporting. In this session, the Inspectorate representative will discuss the scope of the GVP inspections and expectations from the regulator. In addition, a representative from the industry will describe best practices for pharmacovigilance inspections readiness requirements including but not limited to key QMS components. Common questions from the industry pertaining to GVP inspection preparation, conduct, and observations will be addressed.
Learning Objective : - Describe Inspectorate’s expectations during Health Canada GVP inspections
- Describe how to be inspection ready and how to navigate a successful PV inspection
- Apply the acquired information to successfully prepare for GVP inspections
Speaker(s)
Good Pharmacovigilance Practices (GVP) Inspection Program: Current Practices and Future Perspectives
Sandra Boulos, MSc
Health Canada, Canada
Senior Corporate Regulatory and Enforcement Advisor, Health Product Compliance a
Pharmacovigilance Inspection Readiness and Quality System
Bertha V Ferrer, MSc, RPh
Pfizer, United States
Senior Director, Head of Quality Management and Inspections
Good Pharmacovigilance Practices (GVP) Inspection Readiness
Paul Baillargeon
Health Canada, Canada
Regional Regulatory Compliance and Enforcement Specialist, Health Product