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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

  • Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
  • Novo Nordisk A/S, 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

    • Head of Documents Access and Publication Service
    • European Medicines Agency, Netherlands
    Andre  Molgat, PhD

    Speaker

    Andre Molgat, PhD

    • Head of Operations, Public Release of Clinical Information
    • Health Canada, Canada
    Nancy B. Sager, MBA

    Speaker

    Nancy B. Sager, MBA

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

    Q&A Panel Discussion

    Panel Discussion

    • All Session Speakers, United States

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    Short Course 1

    Disclosures 101


    Short Course 2

    Preparing Documents for Disclosure and Public Sharing 


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