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Session 3: The What and How of Transparency of Clinical Trial Information
Session Chair(s)
Yatika Kohli, PhD, MBA
Chief Compliance and Strategy Officer
NoNO Inc, Canada
Marcia Sam
Senior Manager, Regulatory Affairs
Regeneron Canada Company, Canada
As one of the five key pillars of the Government of Canada's Regulatory Innovation Agenda for health products, the modernization of clinical trial regulations is an important goal for Health Canada. In this session, speakers from Health Canada and TransCelerate will focus on the importance regarding the transparency of clinical trial information and measures and will discuss the development of new policies and regulations to make clinical trial information more accessible to the public.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define the wide-reaching benefits of the transparency of clinical trial information
- Describe the transparency measures that Health Canada is contemplating to guide and encourage sponsors for clinical trial registration
- Discuss the impacts and considerations for Industry
Speaker(s)
Speaker
David P. Leventhal, MBA
Pfizer Inc, United States
Enterprise Clinical Trial Data Sharing Lead, Global Data Dissemination
Clinical Trial Transparency in Canada – New Guidance and Public Search Portal
Vinay Dilawri
Health Canada, Canada
Business Analyst
Clinical Trial Transparency in Canada – New Guidance and Public Search Portal
Sarah Topham, MSc
Health Canada, Canada
Policy Analyst, Health Products and Food Branch