返回 Agenda
Session 3 Track C: Post-Market Surveillance
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director, GSK, Canada
Caroline Croteau, PhD, RPh
Country Safety Lead, Pfizer Canada Inc, Canada
Deborah Danoff, MD, FRCPC
Medical Evaluator, Health Canada, Canada
Post-market surveillance requires close collaboration between industry and the regulatory authorities. An essential aspect of post-market surveillance is adverse reaction reporting, a requirement that both industry and regulatory authorities have obligations towards. Industry is exploring innovative methods to gain additional information and facilitate risk mitigation for newer therapies. At the same time, Health Canada has reached out to industry to understand concerns related to proposed changes to the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry This session will explore approaches to post market surveillance from the perspectives of both industry and regulatory authorities. This will include the current revision process of the Guidance Document for Industry including comments received from stakeholders, as well as key changes being considered. Results from a pilot COVID-19 social listening program will also be presented.
Learning Objective : By the end of this session, participants should be able to:
- Describe the extension of patient support programs to include both generics and brand name products
- Outline how extra solicited reports / patient support programs can mitigate risk
- Understand adverse reaction reporting requirements for industry
- Identify the changes that are under consideration in the guidance document in response to stakeholder comments
Speaker(s)
Paul Litowitz, MBA, RAC
Manager, Public and Regulatory Affairs Outreach Section , Health Canada, Canada
Reporting Adverse Reactions to Marketed Health Products Guidance Document for Industry
Manfred Hauben, MD, MPH
Senior Director Product Safety Surveillance and Reporting, Pfizer , United States
Pharmacovigilance Signal Detection and Information Monitoring for COVID-19 Vaccine Using Social Listening