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Session 6, Track C: Monitoring Post-Market Compliance through GVP Inspections and Proactive Risk Management Projects
Session Chair(s)
Myriam Salem, MSc
Pharmacovigilance Manager
Health Canada, Canada
Agnes Jankowicz, MS
Vice President, Pharmacovigilance
Veristat, Canada
The Good Pharmacovigilance Practices (GVP) inspection program at Health Canada monitors the post-market pharmacovigilance compliance of heath products on the market in various ways. One way is through regular GVP inspections that verify how regulated parties meet specific requirements under the Food and Drug Regulations and associated guides for industry. One additional way is through the proactive risk management projects (PRMPs). In addition, the GVP program has been collaborating with international counterparts to take part in various initiatives. This session will give an overview of the ongoing projects, initiatives and future perspectives as well as introduce international collaboration partnerships on various topics including Artificial Intelligence and joint visit inspections.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize ongoing GVP initiatives and projects
- Differentiate between GVP regular inspections and proactive monitoring projects
- Identify international collaboration partnerships including joint visit inspections, experience sharing, and development of guidance documents and procedures
Speaker(s)
Proactive Risk Management Projects (PRMPs)
Camille Proulx
Health Canada, Canada
Senior Corporate Regulatory Compliance and Enforcement Advisor
Speaker
Iva Galic, DMD, MSc
European Medicines Agency, Netherlands
Good Pharmacovigilance Practices (GVP) Inspection Program: Current Practices and Future Perspectives
Myriam Salem, MSc
Health Canada, Canada
Pharmacovigilance Manager