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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

14 sep 2017 7:00 a.m. - 15 sep 2017 3:00 p.m.

1750 Rockville Pike, , Rockville, MD 20852 , USA

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.

Session 1: Access to Regulatory Clinical Documents: Hear from the Regulators

Session Chair(s)

Merete  Joergensen, MBA, MSc

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

    Virtual Presenter

    Anne-Sophie Henry-Eude, PharmD

    European Medicines Agency, Netherlands

    Head of Documents Access and Publication Department

    Andre  Molgat, PhD

    Speaker

    Andre Molgat, PhD

    Health Canada, Canada

    Head of Operations, Public Release of Clinical Information

    Nancy B. Sager, MBA

    Speaker

    Nancy B. Sager, MBA

    FDA, United States

    Director, Division of Information Disclosure Policy, ORP, CDER

      Panel Discussion

    Q&A Panel Discussion

    Panel Discussion

    All Session Speakers, United States

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