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Session 4 - Track B: Inspectorate Town Hall – GVP Inspections
Session Chair(s)
Chanez Narimene Kebache, MBA
Director, Global Product Safety & Pharmacovigilance
Canopy Growth Corporation, Canada
As part of Health Canada’s (HC) mandate to maximize the safety, quality and efficacy of health products, the Health Product and Food Branch (HPFB) Inspectorate posted in 2013 on the HC’s website the new guidance document entitled “Good Pharmacovigilance Practices (GVP) Guidelines” (GUI-0102) and the revision to the “Risk Classification of Good Pharmacovigilance Practices (GVP) Observations” (GUI-0063).
The industry’s perspective on the impact of the implementation of GUI-0102 and GUI-0063 on the conduct of GVP inspections will be discussed with an opportunity for interactive participation by the audience. A HC’s Inspectorate representative will provide an overview of the main deficiencies observed
during GVP inspections that have been conducted since the implementation of GUI-0102.
Speaker(s)
GVP Inspections: Information Update on the Implementation of the Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)
Sophie Lafrance
Health Canada, Canada
Corporate Regulatory Compliance & Enforcement Advisor
Inspectorate Town Hall –Good Pharmacovigilance Practices (GVP) Inspections
Agnes Jankowicz, MS
Veristat, Canada
Vice President, Pharmacovigilance
Robert Milne
EMD Serono, Canada
Head Drug Safety / Medical Information
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