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Regulatory Submissions, Information, and Document Management Forum


Session 7 Track 3: Understanding ICH E6 R2 and the Impact to Clinical Trial Documentation and the Trial Master File

    Session Chair(s)
      Joanne S. Malia

      Joanne S. Malia

      • Associate Director, Clinical Documentation Management
      • Regeneron Pharmaceuticals, United States
    ICH E6 R2 was released in November 2016 and has outlined new expectations for all stakeholders of clinical trials. Additionally, the EMA released its draft guidance on the TMF. This session will discuss the resulting expectations impacting clinical trial documentation and the Trial Master File (TMF). The impact and response from different stakeholders such as vendors, sponsors, and regulators will be presented and discussed.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Understand new and coming expectations for TMF management due to ICH E6 R2 and EMA draft TMF guidance
    • Distinguish draft EMA TMF Guidance boundaries from inspection requirements
    • Recognize and take away practical strategies for eTMF compliance to regulations
    Speaker(s)
      Fran  Ross

      eTMF Compliance: Impact of ICH E6 R2 Update and EMA Draft TMF Guidance

      Fran Ross

      • Senior Consultant
      • GCI, United States
      Joanne S. Malia

      Speaker

      Joanne S. Malia

      • Associate Director, Clinical Documentation Management
      • Regeneron Pharmaceuticals, United States
      Ann  McCabe

      Speaker

      Ann McCabe

      • Director, Process Excellence & Risk Management
      • Daiichi Sankyo Inc, United States
      Representative Invited

      Speaker

      Representative Invited

      • FDA, United States