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Session 1: Access to Regulatory Clinical Documents: Hear from the Regulators
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
Merete-J Consulting CVR: 34920818, Denmark
This first session on Access to Regulatory Documents will focus on the regulators’ perspectives while highlighting similarities and differences among the different approaches in EU, US, and Canada. A proactive approach to access to regulatory clinical documents submitted under the centralized procedure has been implemented by EMA’s launch of a specific website. EMA has issued further guidance on the implementation of its Policy 0070 - EMA/240810/2013, and EMA/90915/2016. In March 2017 Health Canada published its intent of a similar approach in the Public release of Clinical Information in Drug Submissions and Medical Device Applications.
Learning Objective :
Speaker(s)
Virtual Presenter
Anne-Sophie Henry-Eude, PharmD
European Medicines Agency, Netherlands
Head of Documents Access and Publication Department
Speaker
Andre Molgat, PhD
Health Canada, Canada
Head of Operations, Public Release of Clinical Information
Speaker
Nancy B. Sager, MBA
FDA, United States
Director, Division of Information Disclosure Policy, ORP, CDER
Q&A Panel Discussion
Panel Discussion
All Session Speakers, United States
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