Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

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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, Merete-J Consulting, 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 :
Identify the most current thinking of the regulators on public access to regulatory documents
Differentiate the similarities and differences in the implementation in EU, US, and Canada
Describe the critical issues and questions

Speaker(s)

Anne-Sophie Henry-Eude, PHARMD

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

Virtual Presenter

Andre Molgat, PHD

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

Speaker

Nancy B. Sager, MBA

Director, Division of Information Disclosure Policy, ORP, CDER, FDA, United States