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Session 4: Track A: Regulatory Renewal: More on the Regulatory Changes Implemented and Being Proposed
Session Chair(s)
Lisa Chartrand
Director, Regulatory Strategy and Policy
Hoffmann-La Roche Limited, Canada
Following on from Session 3A, given the unprecedented number of regulatory changes being proposed in the last year (and in the next few years to come) which affect various stages of a product’s lifecycle in Canada, this session will summarize, consolidate, clarify, and help to ensure as an industry and consumers that we are all prepared.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the overarching mandate to the various regulatory changes being implemented and proposed
- Describe the role of stakeholder input as part of the open consultation process
- Prepare your organization for the regulatory changes
Speaker(s)
Speaker
Bruno Rodrigue
Health Canada, Canada
Director, Office of Legislation and Regulatory Modernization
Speaker
Kristen Beausoleil
Health Canada, Canada
Manager, Economic Analysis, Office of Legislative and Regulatory Modernization
Proposal for the Environmental Risk Assessment of Medicinal Ingredients in Human and Veterinary Drugs
Julie Chateauvert, MS
Health Canada, Canada
Senior Scientific Project Coordination Biologist
Industry Impact Regulatory Changes
Jared Rhines
AKCEA Therapeutics Canada Inc, Canada
General Manager