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Ottawa Marriott Hotel

Oct 27, 2015 8:30 AM - Oct 28, 2015 3:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2015

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Session 6 Track B - Labeling and Advertising and Promotion: The Product Monograph Project

Session Chair(s)

Vratislav Hadrava, MD, PhD

Vratislav Hadrava, MD, PhD

Vice President and Medical Director, Global Innovative Products

Pfizer Canada, Inc., Canada

This session will provide an overview of the ongoing review of the Product Monograph content and format including areas of the monograph under examination and proposals for a new format. This session will also provide insight from two stakeholders who contributed to the consultation phase of this project, PAAB and the industry as discussed within an Rx&D sub-committee. Rx&D will provide insights into the critical importance of the Product Monograph, efforts made to ensure the accuracy and international consistency of the content, and the industry perspective on recent Health Canada proposals affecting the Product Monograph. PAAB will speak to the implications of the various proposed changes to the Product Monograph, including the streamlined referencing process, and how they could affect the review process for advertising drugs.

Speaker(s)

The Health Canada Product Monograph Project

Madeleine Marshall

Health Canada, Canada

Manager, Policy Division, Bureau of Policy, Science and International Programs

Overview of Industry Comments on the Product Monograph

Sandra Wainwright

Merck Canada Inc., Canada

Exec. Dir., Regulatory Liaison

Implications For Advertising And Promotions Campaigns Based On The Proposed Product Monograph Changes

Jennifer Carroll

Pharmaceutical Advertising Advisory Board (PAAB), Canada

Reviewer/Training

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