Back to Agenda
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, ClaroPV Services Inc, 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)
Sandra Boulos, MSC
Senior Corporate Regulatory and Enforcement Advisor, Health Product Compliance a, Health Canada, Canada
Good Pharmacovigilance Practices (GVP) Inspection Program: Current Practices and Future Perspectives
Bertha V Ferrer, MSC, RPH
Senior Director, Head of Quality Management and Inspections, Pfizer, United States
Pharmacovigilance Inspection Readiness and Quality System
Paul Baillargeon
Regional Regulatory Compliance and Enforcement Specialist, Health Product, Health Canada, Canada
Good Pharmacovigilance Practices (GVP) Inspection Readiness
Have an account?