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Virtual Event

Oct 21, 2020 10:25 AM - Oct 22, 2020 4:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Canadian Pharmacovigilance and Risk Management Conference

Session 5: Notifying Health Canada of Foreign Actions

Session Chair(s)

Rita  Cassola, RPh

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)

Bruce  Wozny, MA

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

Eian  Elliott, MBA

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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