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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 2: Access to Regulatory Clinical Documents: Sponsors’ Experiences

Session Chair(s)

Patricia A. Teden, MBA

Patricia A. Teden, MBA

  • President and Principal
  • Teden Consulting LLC, United States
This is the second session on Access to Regulatory Clinical Documents, and focuses on the Sponsors’ experience. Both the EU and US require regulatory documents be made available on public portals, and Canada announced their intention to do the same. These requirements raise issues regarding protecting personal confidentiality and corporate confidential information. Initial standards have been documented by a few groups, and ‘tested’ by actual experience posting documents on the EMA’s website. This session will focus on the experience of sponsors who have prepared and posted regulatory clinical documents, including technical issues (such as redaction), corporate process issues, and communication with regulators.
Learning Objective :
  • Recognize the principles for data that regulators and sponsors agree can/should be redacted
  • Identify different options for redacting clinical documents that will be posted publicly
  • Guide the development of an internal process that covers a process that meets regulations and emerging standards
  • Speaker(s)

    Julie G. Holtzople

    Speaker

    Julie G. Holtzople

    • Clinical Trial Transparency Operations Director
    • AstraZeneca, United States
    Milena  Vakrilova

    Speaker

    Milena Vakrilova

    • Regulatory Intelligence Manager
    • Novartis Pharmaceuticals Corporation, Switzerland
      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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