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Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

Session 8 Track 2B: Brave New World: Planning for Global Submissions in a Post-Disclosure World

    Session Chair(s)
      Robert  Paarlberg, MS

      Robert Paarlberg, MS

      • Principal
      • Paarlberg & Associates LLC, United States
    Clinical trial disclosure requirements of the Final Rule and EMA’s proactive publication of clinical data under Policy 0070 are having a significant impact on company processes and strategies. This session will be a panel discussion on hot topics in clinical trial disclosure/transparency and how they are impacting company processes and strategies as well as impact on the orphan/rare disease community. Topics to be addressed include: how disclosure requirements are impacting clinical development strategies; commercial confidential information; individual personal data; potential legal implications to patients and companies; and impact on the orphan/rare disease community.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Identify key areas within a company impacted by the Final Rule and EMA Policy 0070
    • Describe how disclosure/transparency requirements are impacting approaches to protocol and clinical study report writing
    • Discuss potential legal implications that disclosure is having in the US and EU
    • Describe how disclosure/transparency is impacting orphan/rare disease community
      Deborah E. Collyar


      Deborah E. Collyar

      • President
      • Patient Advocates In Research (PAIR), United States
      Mark  Barnes, JD


      Mark Barnes, JD

      • Partner
      • Ropes & Gray, LLP, United States
      Kelly  Vaillant


      Kelly Vaillant

      • Global Head, Clinical Trial Disclosures & Data Transparency
      • Gilead Sciences, Inc., United States
      Rebecca J. Williams, PharmD, MPH


      Rebecca J. Williams, PharmD, MPH

      • Assistant Director,, NCBI
      • National Library of Medicine, NIH, United States