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Delta Hotels Ottawa City Centre

Oct 18, 2022 1:00 PM - Oct 19, 2022 9:10 PM

101 Lyon Street North, Ottawa, ON K1R 5T9, Canada

Canada Annual Meeting

Session 6, Track C: Monitoring Post-Market Compliance through GVP Inspections and Proactive Risk Management Projects

Session Chair(s)

Myriam  Salem, MSc

Myriam Salem, MSc

Pharmacovigilance Manager

Health Canada, Canada

Agnes  Jankowicz, MS

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)

Camille  Proulx

Proactive Risk Management Projects (PRMPs): Camille Proulx

Senior Corporate Regulatory Compliance and Enforcement Advisor

Health Canada, Canada

Iva  Galic, DMD, MSc

Speaker: Iva Galic, DMD, MSc

European Medicines Agency, Netherlands

Myriam  Salem, MSc

Good Pharmacovigilance Practices (GVP) Inspection Program: Current Practices and Future Perspectives: Myriam Salem, MSc

Pharmacovigilance Manager

Health Canada, Canada

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