Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join


Dec 05, 2023 1:15 PM - Dec 07, 2023 7:00 PM

(Central Europe Standard Time)

DIA Global Clinical Trial Disclosure and Data Transparency Conference

This virtual live conference is a must-attend for anyone involved in clinical trials!

Session 10: Update on Clinical Document Disclosure policies/restart activities: EU and Canada

Session Chair(s)

Thomas  Schindler, PhD

Thomas Schindler, PhD

Director Global Regulatory Affairs - Regulatory Operations

BioNTech SE, Germany

Lora  Killian, MBA

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.


Andre  Molgat, PhD

Update on Clinical Data Publication policies in EU and Canada

Andre Molgat, PhD

Health Canada, Canada

Head of Operations, Public Release of Clinical Information

Anne-Sophie  Henry-Eude, PharmD

Update on Clinical Data Publication policies in EU and Canada

Anne-Sophie Henry-Eude, PharmD

European Medicines Agency, Netherlands

Head of Documents Access and Publication Department

Catherine  Brown

Sponsor Experience Submitting to EMA Policy 0070 Post-Restart

Catherine Brown

Pfizer Inc., United States

Clinical Trial Transparency and Disclosure Manager

Wendy M Wimmer, MS

Contributing Panelist

Wendy M Wimmer, MS

Merck & Co., Inc., United States

Director, Clinical Data Disclosure and Transparency

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.