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Hilton London Docklands Riverside Hotel

Sep 19, 2018 8:00 AM - Sep 20, 2018 5:00 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Global Clinical Trials Transparency Conference

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Session 1: Sharing Clinical Study Reports

Session Chair(s)

Francine Lane, MBA

Francine Lane, MBA

Sr. Director of Product Mgmt

Citeline, United States

Olivia Shopshear, MS

Olivia Shopshear, MS

Senior Director, US Regulatory Policy Lead

Biogen, United States

The FDA, EMA and Health Canada will all share clinical study information in the public domain. What are the differences between the Regulators on what clinical information will be shared? How does this impact industry?

Speaker(s)

Anne-Sophie Henry-Eude, PharmD

EMA Clinical Data Publication Policy 0070 : Anne-Sophie Henry-Eude, PharmD

Head of Documents Access and Publication Department

European Medicines Agency, Netherlands

Health Canada Initiative: Health Canada’s Draft Guidance on Public Release of Clinical Information: Andre Molgat, PhD

Head of Operations, Public Release of Clinical Information

Health Canada, Canada

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