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Session 5, Track C: Notification of Foreign Actions: Challenges and Best Practices
Session Chair(s)
Nadia Latif, MS
Senior Manager, Pharmacovigilance, Ipsen Biopharmaceuticals Canada Inc., Canada
Nadiya Jirova, MSC
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products, Health Canada, Canada
Agnes Jankowicz, MS
Vice President, Pharmacovigilance, ClaroPV Services Inc, Canada
Health Canada first published the Notifying Health Canada of Foreign Actions guidance in November 2018. As industry has now had some time to become familiar with this requirement, this session will provide an update on Health Canada’s experience with Notifications of Foreign Actions (NFA) process, provide practical feedback on the process and identify potential areas for improvement and collaboration with the industry. The session will also provide perspective from industry on best practices when dealing with actions from foreign regulators. Attendees will also be able to ask specific questions to Health Canada representatives.
Speaker(s)
Bruce Wozny, MA
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products, Health Canada, Canada
Notification of Foreign Actions: An Update by Health Canada
Randy Levitt, PHD
Director, Pharmacovigilance, Medical Information and Patient Support, Knight Therapeutics Inc., Canada
Foreign Alerts: An Industry Perspective
Koby Philip-Joseph
Regional Regulatory Compliance and Enforcement Officer, Health Canada, Canada
Good Pharmacovigilance Practices (GVP) Inspections: Notification of Foreign Actions
Paul Baillargeon
Regional Regulatory Compliance and Enforcement Specialist, Health Product, Health Canada, Canada
Speaker
Andrea Bell, PHD
Human Therapeutic Product Submission Assessment Evaluator, Health Canada, Canada
Notification of Foreign Actions: An Update by Health Canada
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