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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program

    Session Chair(s)
      Robert  Paarlberg, MS

      Robert Paarlberg, MS

      • Principal
      • Paarlberg & Associates LLC, United States
    Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.
    Learning Objective : Identify key areas impacted by Policy 0070 and the NIH Final Rule, challenges and approaches for compliance; Describe experiences with redaction packages; Discuss how companies are approaching EMA, ClinicalTrials.gov and FDA’s new pilot clinical document requirements and identify best practices.
    Speaker(s)
      Rosalynd  Cole

      The Evolution of Clinical Data Transparency: Managing Policy 0070 Requirements of the Future to Maximize Compliant Efficiency

      Rosalynd Cole

      • Senior Manager
      • Jazz Pharmaceuticals, United Kingdom
      Marie Isabel Manley, LLM

      Disclosing Data: EMA Policies 0043/0070, EudraCT, and the Clinical Trial Regulation - Where Are We Now?

      Marie Isabel Manley, LLM

      • Partner, Head of the UK Life Sciences
      • Sidley Austin LLP, United Kingdom
      Rebecca J. Williams, PharmD, MPH

      Update from ClinicalTrials.gov

      Rebecca J. Williams, PharmD, MPH

      • Assistant Director, ClinicalTrials.gov, NCBI
      • National Library of Medicine, NIH, United States
      Olivia  Shopshear, MS

      Beyond Disclosure: Working Toward Better Outcomes for Patients

      Olivia Shopshear, MS

      • Senior Director, Science and Regulatory Advocacy
      • PhRMA, United States
      Ann M. Witt, JD

      FDA’s Pilot to Enhance Transparency of Clinical Trial Information

      Ann M. Witt, JD

      • Counselor to DC for Policy, OND, CDER
      • FDA, United States
      Anne-Sophie  Henry-Eude, PharmD

      EMA Update

      Anne-Sophie Henry-Eude, PharmD

      • Head of Documents Access and Publication Service
      • European Medicines Agency (EMA), United Kingdom