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Hilton London Docklands Riverside Hotel

19 sep 2018 8:00 a.m. - 20 sep 2018 5:00 p.m.

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

Senior Director of Product Management, 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

Anne-Sophie Henry-Eude, PharmD

Head of Documents Access and Publication Department, European Medicines Agency, Netherlands

EMA Clinical Data Publication Policy 0070

Andre Molgat, PhD

Andre Molgat, PhD

Head of Operations, Public Release of Clinical Information, Health Canada, Canada

Health Canada Initiative: Health Canada’s Draft Guidance on Public Release of Clinical Information

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