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Session 4, Track A: Health Canada, the Industry, and the Future of Oncology Approvals
Session Chair(s)
My (may) Dang, MBA
Director, Regulatory Affairs, Cencora, Canada
Melanie Cote, MS
Senior Manager, Global Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization Inc., Canada
International collaboration is reshaping the regulatory landscape. This session will explore Health Canada’s evolving relationship with the FDA, examining key milestones, as well as current and future initiatives. Industry experts will provide their experience into the impact of Project Orbis on accelerating global oncology approvals across multiple countries as well as sharing data-driven perspectives on its effectiveness in streamlining access to innovative treatments.
- Project Orbis at Health Canada: The Regulator’s Perspective
Melissa Hunt, MSc, Health Canada - Analysis of Project Orbis Participation by Health Canada on New and Supplemental Drug Submissions: An Industry Perspective
Jonathan Zaslavsky, AstraZeneca Canada - Project Orbis: An Industry Perspective
Sabrina Moers, Merck Canada Inc.
Learning Objective : - Examine the concurrent partnership between Health Canada, the industry, and other Health Agencies around the world on Project Orbis and future plans aimed at enhancing regulatory cooperation
- Share data-driven perspectives on the effectiveness of international collaboration in streamlining access to innovative treatments
- Hear from industry experts how these collaborations influence the development and approval of new treatments in oncology
Speaker(s)
Melissa Hunt, MSC
Director, Health Canada, Canada
Project Orbis at Health Canada: The Regulator’s Perspective
Jonathan Zaslavsky, MSC
Regulatory Affairs Associate, AstraZeneca Canada, Canada
Analysis of Project Orbis Participation by Health Canada on New and Supplemental Drug Submissions: An Industry Perspective
Sabrina Moers, MSC
Director Regulatory Affairs, Merck & Co., Inc., Canada
Project Orbis: An Industry Perspective
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