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DIA 2018 Global Annual Meeting


Clinical Trial Results Disclosure: What Have We Learned from EMA Policy 0070 Implementation and ClinicalTrials.gov Postings?

    Session Chair(s)
      Robert  Paarlberg, MS

      Robert Paarlberg, MS

      • Principal
      • Paarlberg & Associates LLC, United States
    This session will discuss how companies are approaching the Policy 0070 and Final Rule requirements. The session will also provide the latest updates on Policy 0070 and the Final Rule from EMA and ClinicalTrials.gov staff. The panel will include representatives from EMA, National Library of Medicine (ClinicalTrials.gov) and industry speakers from mid-size and large pharma.
    Learning Objective : Identify key areas impacted by the Final Rule and Policy 0070; Discuss approaches companies are taking in order to comply;Discuss challenges of Policy 0070; Describe experiences with redaction packages; Discuss how companies are approaching EMA and ClinicalTrials.gov document requirements; 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

      • Accenture UK Ltd, United Kingdom
      Marie  Manley, LLM

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

      Marie Manley, LLM

      • Partner and Head of the Regulatory Practice
      • Bristows 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