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Session 10: Update on Clinical Document Disclosure policies/restart activities: EU and Canada
Session Chair(s)
Thomas Schindler, PHD
Director Global Regulatory Affairs - Regulatory Operations, BioNTech SE, Germany
Lora Killian, MBA
Clinical Trial Transparency and Disclosure Lead, Pfizer, United States
This session will provide an update on EMA Policy 0070 and Health Canada’s Public Release of Clinical Information (PRCI). Speakers will provide EMA’s and sponsor perspectives regarding the restart of Policy 0070 scheduled for Sep 2023, its scope, related organisational adaptations, alignment with Health Canada’s PRCI, and first practical experiences. Health Canada will present on status and progress of PRCI which reached its final implementation stage in March 2023 and now encompasses dossiers of class III and IV medical devices.
Speaker(s)
Andre Molgat, PHD
Head of Operations, Public Release of Clinical Information, Health Canada, Canada
Update on Clinical Data Publication policies in EU and Canada
Anne-Sophie Henry-Eude, PHARMD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
Update on Clinical Data Publication policies in EU and Canada
Catherine Brown
Clinical Trial Transparency and Disclosure Manager, Pfizer Inc., United States
Sponsor Experience Submitting to EMA Policy 0070 Post-Restart
Wendy M Wimmer, MS
Director, Clinical Data Disclosure and Transparency, Merck & Co., Inc., United States
Contributing Panelist
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