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Global Clinical Trials Transparency Conference


Session 1: Sharing Clinical Study Reports

Session Chair(s)

Francine  Lane, MBA

Francine Lane, MBA

  • Vice President, Global Transparency
  • TrialScope, United States
Olivia  Shopshear, MS

Olivia Shopshear, MS

  • Senior Director, Science and Regulatory Advocacy
  • Pharmaceutical Research and Manufacturers of America (PhRMA), 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 Service
  • European Medicines Agency, Netherlands
Andre  Molgat, PhD

Health Canada Initiative: Health Canada’s Draft Guidance on Public Release of Clinical Information

Andre Molgat, PhD

  • Senior Regulatory Affairs Advisor, Resource Management and Operations Directorat
  • Health Canada, Canada