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Ottawa Marriott Hotel

2018 年 10 月 30 日 7:00 上午 - 2018 年 10 月 31 日 3:00 下午

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Transformation with Collaboration

Session 4: Track A: Regulatory Renewal: More on the Regulatory Changes Implemented and Being Proposed

Session Chair(s)

Lisa  Chartrand

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)

Bruno  Rodrigue

Bruno Rodrigue

Director, Office of Legislation and Regulatory Modernization, Health Canada, Canada

Speaker

Kristen  Beausoleil

Kristen Beausoleil

Manager, Economic Analysis, Office of Legislative and Regulatory Modernization, Health Canada, Canada

Speaker

Julie  Chateauvert, MS

Julie Chateauvert, MS

Senior Scientific Project Coordination Biologist, Health Canada, Canada

Proposal for the Environmental Risk Assessment of Medicinal Ingredients in Human and Veterinary Drugs

Jared  Rhines

Jared Rhines

General Manager, AKCEA Therapeutics Canada Inc, Canada

Industry Impact Regulatory Changes

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