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Session 5: Notifying Health Canada of Foreign Actions
Session Chair(s)
Rita Cassola, RPh
Executive Director PV
Certus PV Services Inc, Canada
This session will provide a high-level overview on the requirement to notify Health Canada of foreign actions, including the purpose of the regulation C.01.050, the corresponding guidance and the reporting form.
Since the regulation came into force in November 2018, Health Canada has received a number of questions from the industry and will share the answers to these questions during this session.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand what actions should be notified
- Understand how to notify
- Understand where to send questions regarding Regulation (....), depending on the nature of the question
Speaker(s)
Notification of Foreign Regulatory Actions – Compliance Questions and Answers
Bruce Wozny, MA
Health Canada, Canada
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products
Notification of Foreign Regulatory Actions – Compliance Questions and Answers
Eian Elliott, MBA
Health Canada, Canada
Senior Corporate Regulatory Compliance & Enforcement Advisor
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