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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 3: Track A: Exploring New Pathways to Market

Session Chair(s)

Melissa  Hunt, MSc

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

International Work Sharing at Health Canada

Craig Simon, PhD

Health Canada, Canada

Acting Director, Bureau of Pharmaceutical Sciences, TPD

Sarah  Lussier Hoskyn, MA

Factors Associated with Regulatory Filing and Approval Timelines of New Medicines in Canada

Sarah Lussier Hoskyn, MA

Innovative Medicines Canada, Canada

Senior Analyst, Regulatory Affairs and Market Access

Megan  Bettle, PhD

Early Scientific Advice at Health Canada

Megan Bettle, PhD

Health Canada, Canada

Léo  Bouthillier, PhD

The Proposed Use of a Foreign Decision Pathway

Léo Bouthillier, PhD

Health Canada, Canada

Director, Bureau of Cardiology, Allergy and Neurological Sciences, Therapeutic P

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