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Ottawa Marriott Hotel

Oct 18, 2016 8:00 AM - Oct 19, 2016 4:00 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting 2016

Explore how innovation can support new initiatives, regulatory processes, research, transparency, engagement, personalized medicine, and use of real-world data in Canada.

Session 5 Track A: Transparency and Openness

Session Chair(s)

Vratislav  Hadrava, MD, PhD

Vratislav Hadrava, MD, PhD

Vice President and Medical Director, Global Innovative Products

Pfizer Canada, Inc., Canada

The session will review the pre-market transparency initiatives underway within the Health Products and Food Branch, provide update and next steps as well as the evolution of the post-market clinical data transparency within industry, the different models of data sharing initiatives and industry endorsement of data sharing principles.

Learning Objective : At the conclusion of the session, participants should be able to: • Define the pre-market transparency initiatives underway within the Health Products and Food Branch • Understand the progression of the initiatives since their inception • Identify possibilities for future expansion of the transparency initiatives

Speaker(s)

Jessica S. Scott, JD, MD

Speaker

Jessica S. Scott, JD, MD

Legacy Health Strategies , United States

President

Laura  Johnson

Update on Premarket Transparency in the Health Products and Food Branch, Health Canada

Laura Johnson

Health Canada, Canada

Project Manager

Rebecca  Bose

Speaker

Rebecca Bose

Health Canada, Canada

Policy Division-Policy Science Int'l Programs, Therapeutic Products Directorate

Sandra A. Morris, PhD, PMP

Speaker

Sandra A. Morris, PhD, PMP

Johnson & Johnson, United States

Vice President, Strategy Realization

Marla Jo  Brickman, PhD

Speaker

Marla Jo Brickman, PhD

Pfizer Inc, United States

Senior Director - Clinical Data Transparency/Compassionate Access Lead

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