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Session 3: Track A: Exploring New Pathways to Market
Session Chair(s)
Melissa Hunt, MSC
Director, Health Canada, Canada
This session will explore factors associated with regulatory approval timing in Canada as well as initiatives underway to explore different pathways to market in Canada. This session will include perspectives from both industry and Health Canada. Specific topics that will be discussed include factors associated with filing and approval for new drugs in Canada, international worksharing and use of foreign reviews/decisions at Health Canada, and how Health Canada is exploring engagement earlier in drug development.
Learning Objective : At the conclusion of this session, participants should be able to:- Review the factors associated with timing of filing and approval for new drugs in Canadan
- Describe new pathways to market being explored by Health Canadan
- Identify opportunities for future innovative approaches to obtaining drug approval in Canada
Speaker(s)
Craig Simon, PHD
Acting Director, Bureau of Pharmaceutical Sciences, TPD, Health Canada, Canada
International Work Sharing at Health Canada
Sarah Lussier Hoskyn, MA
Senior Analyst, Regulatory Affairs and Market Access, Innovative Medicines Canada, Canada
Factors Associated with Regulatory Filing and Approval Timelines of New Medicines in Canada
Megan Bettle, PHD
, Health Canada, Canada
Early Scientific Advice at Health Canada
Léo Bouthillier, PHD
Director, Bureau of Cardiology, Allergy and Neurological Sciences, Therapeutic P, Health Canada, Canada
The Proposed Use of a Foreign Decision Pathway