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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 4: Preparing for Results Submission Under Final Rule and Other Global Requirements - Panel Discussion

Session Chair(s)

Erik  Lakes, MS, MSc

Erik Lakes, MS, MSc

  • Director, Clinical Study Disclosure
  • PRA Health Sciences, United States

Are you prepared for submitting results under the new Final Rule requirements? How do the final regulations impact your company’s disclosure timelines? Are your protocols and SAPs ready for public disclosure? What actions do you need to take now to ensure compliance in 2018? This panel discussion will include perspectives from both industry and legal, and will include impact on other global requirements.

Learning Objective :
  • Describe Final Rule results requirements and impact on your company’s existing disclosure policy
  • Review different perspectives on how other sponsors are preparing for submissions
  • Prepare a checklist of action items in preparation of 2018 implementation
  • Speaker(s)

    René  Allard, PhD


    René Allard, PhD

    • Contractor
    • Self Employed, Germany
    David  Peloquin, JD


    David Peloquin, JD

    • Senior Advisor, MRCT Center; Associate, Health care Group
    • Ropes & Gray LLP, United States
    Ramona L Rorig


    Ramona L Rorig

    • Associate Director Clinical Trial Disclosure
    • Astellas Pharma Global Development, 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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