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Ottawa Marriott Hotel

Oct 29, 2013 8:30 AM - Oct 30, 2013 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA's Annual Canadian Meeting: New Reality / New Frontiers

Session 3 Track 1 - New Frontiers: Harmonizing in the Post-Approval Pharmacovigilance: Challenges and Opportunities

Session Chair(s)

Vratislav  Hadrava, MD, PhD

Vratislav Hadrava, MD, PhD

Vice President and Medical Director, Global Innovative Products

Pfizer Canada, Inc., Canada

Pharmacovigilance is a rapidly evolving and increasingly global field. Government and Industry are often criticised for taking action in one jurisdiction not always harmonised to action in another. With the near instantaneous dissemination of information and the different global regulatory practices with respect to risk management, the regulators and the pharmaceutical industry are faced with challenges in trying to find the best way to manage risk while at the same time meeting expectations from various stakeholders. This session will provide the perspective of Health Canada, Industry and other stakeholders to provide understanding and appreciation of the current practices, consumers’ expectations, challenges and opportunities for change. The expectations of global harmonisation will also be explored.

Speaker(s)

Melissa  Hunt, MSc

Challenges and Opportunities in Post Market Pharmacovigilance: A Canadian Perspective

Melissa Hunt, MSc

Health Canada, Canada

Director

Dianne  Azzarello

Presenter

Dianne Azzarello

Celgene Inc., Canada

Director, Pharmacovigilance and Regulatory

Yola  Moride, PhD, FISPE

Harmonizing in the Post-Approval Pharmacovigilance: Challenges and Opportunities

Yola Moride, PhD, FISPE

YolaRX Consultants, Canada

President

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