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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 2: Access to Regulatory Clinical Documents: Sponsors’ Experiences

Session Chair(s)

Patricia  Teden, MBA

Patricia 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  Holtzople

    Speaker

    Julie Holtzople

    Holtzople Consulting, United States

    President

    Milena  Vakrilova

    Speaker

    Milena Vakrilova

    Novartis Pharmaceuticals Corporation, Switzerland

    RA Head Strategic Operations and Compliance, Region Europe

      Panel Discussion

    Q&A Panel Discussion

    Panel Discussion

    All Session Speakers, United States

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