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Session 2 Track C: Round Table on GVP Inspections
Session Chair(s)
Agnes Jankowicz, MS
Vice President, Pharmacovigilance
ClaroPV Services Inc, Canada
The Good Pharmacovigilance Practices (GVP) Inspection program is intended to verify that health product manufacturers meet the requirements of the Food and Drug Regulations pertaining to ADR reporting. In this session, you will learn from the Inspectorate about GVP inspection trends observed during the fiscal year 2020-2021 and on-going initiatives within the Program.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify most common inspection findings observed in recent Health Canada GVP inspections
- Understand what is expected during Health Canada GVP inspections
- Understand how to best prepare for a GVP inspection
Speaker(s)
Speaker
Marc-André Giguère
Health Canada, Canada
Senior Policy Analyst