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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

2017 年 09 月 14 日 7:00 上午 - 2017 年 09 月 15 日 3:00 下午

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.

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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

Senior Director and Head, Data Disclosure & Transparency, Beigene, 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, CTC, Germany

    Panelist

    David Peloquin, JD

    David Peloquin, JD

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

    Panelist

    Ramona L Rorig

    Ramona L Rorig

    Associate Director Clinical Trial Disclosure , Astellas Pharma Global Development, United States

    Panelist

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