Proposed Updates to Good Pharmacovigilance Practices (GVP) Guidelines

Health Canada has released proposed updates to the “Good Pharmacovigilance Practices (GVP) Guidelines” (GUI-0102) and the “Risk Classification Guide for GVP Observations” (GUI-0063), both of which are now open for public consultation through October 30, 2025. These evolving regulatory expectations present challenges for Market Authorization Holders (MAHs) aiming to maintain compliance. This webinar will cover the proposed revisions and examine their potential impact on GVP inspections and compliance frameworks.

The extensive proposed revisions to GUI-0102 and GUI-0063 aim to facilitate understanding of how to comply with regulations for HC GVP inspections, as well as explain how risks and overall inspection rating are assigned in HC GVP inspections. The scope of the guidelines includes pharmaceutical drugs, biologics, radiopharmaceuticals and medical gases. The revisions incorporate new and changing GVP requirements, including foreign actions notification and risk management planning, as well as expand on previously captured requirements. In addition to guiding MAHs on how to comply with GVP requirements, both documents guide HC’s inspectorate staff on how the rules are enforced in a fair, consistent and effective way across Canada.

This webinar will explore the impact of the proposed changes on how Canadian MAHs conduct GVP activities in a consistent, reliable and verifiable manner that ensures successful outcomes of GVP inspections.

The Q&A session will provide a forum for open discussion, the exchange of experiences and feedback on the proposed changes, to compile input that can be shared with the regulatory agency.

Register for this webinar to learn how Health Canada’s proposed good pharmacovigilance practices will impact GVP compliance and inspections.

Speakers

Agnes Jankowicz, Vice President of Pharmacovigilance, ClaroPV

Agnes Jankowicz is an industry leader with over twenty years of experience in pharmacovigilance (PV) and medical information (MI), both in the pharmaceutical industry as well as in the consulting environment. She is a Vice President of Pharmacovigilance at ClaroPV, whose team includes experienced and dedicated PV & MI professionals. Agnes is an expert PV auditor and a recognized pharmacovigilance educator engaged in teaching pharmacovigilance courses and presenting on various PV topics. Agnes holds a graduate degree in Pharmacology & Toxicology and, before joining the pharmaceutical industry, was involved in academic research.

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Anna Bussel, Vice President, Pharmacovigilance and Medical Information, ClaroPV Services Inc.

Anna Bussel is a pharmaceutical professional with 15+ years of experience in pharmacovigilance (PV), regulatory affairs (RA) and quality assurance (QA). She is a Vice President of Pharmacovigilance and Medical Information at ClaroPV Services Inc. Her career spans both the pharmaceutical industry, having held PV, RA and QA roles at Eli Lilly and Company, and consulting, where she headed the PV & MI Department at Veristat, Science-First™ CRO, providing strategic PV & MI advice to multiple clients. She has led numerous GVP and GMP audits on behalf of Marketing Authorisation Holders and liaised with Health Authorities on market access and drug policy improvements. Anna holds a Master’s in Pharmacy and is an active member of the DIA.

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