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Session 5 Track A: Transparency and Openness
Session Chair(s)
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)
Speaker
Jessica S. Scott, JD, MD
Legacy Health Strategies , United States
President
Update on Premarket Transparency in the Health Products and Food Branch, Health Canada
Laura Johnson
Health Canada, Canada
Project Manager
Speaker
Rebecca Bose
Health Canada, Canada
Policy Division-Policy Science Int'l Programs, Therapeutic Products Directorate
Speaker
Sandra A. Morris, PhD, PMP
Johnson & Johnson, United States
Vice President, Strategy Realization
Speaker
Marla Jo Brickman, PhD
Pfizer Inc, United States
Senior Director - Clinical Data Transparency/Compassionate Access Lead