Tuesday July 21, 2026 | 8:30 am – 4:30 pm EDT
Montreal, PQ
Pharmacovigilance Workshop
Pharmacovigilance, or drug safety, is a critical component of the life cycle of pharmaceutical products. This training will discuss the requirements from Health Canada’s Guidance Document on pharmacovigilance and offer insight and tools on how to comply.
More specifically, this workshop examines the post-marketing requirements of licensed healthcare products (including cannabis) as well as the ongoing maintenance of the product’s benefit/risk profile throughout the product life cycle.
Attendees will learn and apply the regulatory aspects of pharmacovigilance systems, including receipt and assessment of case reports, signal detection and inputs to periodic summary reports. Key concepts such as safety information resulting in labeling changes and principles of risk management systems will also be covered.
✨ Exclusive Workshop Insights
As an added benefit, this session will include:
- Discussion of draft Health Canada guidance documents, including:
- Notification of Foreign Regulatory Action
- Preparation of Annual Summary Reports
- Firsthand insights from recent discussions with Health Canada, providing clarity on evolving expectations
- Practical tips to streamline compliance, including navigating and downloading adverse reaction reports from Canada Vigilance—helping Market Authorization Holders (MAHs) reduce burden and improve efficiency
✨ Outline:
- Adverse event intake, triage and causality assessment
- Sources of adverse events (solicited and unsolicited)
- Elements of an effective pharmacovigilance system
- Comparison between different periodic summary reports (PSUR, PBRER, PADER)
- Signal detection and assessment (including Notification of Foreign Regulatory Action to Health Canada)
- Principles of risk management plans
- Inputs to label changes (confirmed signal, periodic review of core label, product recall)
- Details of Cannabis adverse reaction reporting guide
All registered attendees will receive a Health Canada recognized Certificate of Completion, along with an e-badge for their training records.
For more information : https://psg.ca/training-and-events/#!event/2026/4/14/ai-meets-compliance-8212-shaping-the-future-of-pharma
