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DIA 2018 Global Annual Meeting


FDA Data Standards Update

    Session Chair(s)
      Ron D. Fitzmartin, DIAFellow, PhD, MBA

      Ron D. Fitzmartin, DIAFellow, PhD, MBA

      • Senior Advisor, Office of Strategic Programs, CDER
      • FDA, United States
    The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will implement a joint data standards strategy, with supporting action plan. The action plan is now a PDUFA VI commitment to industry. The strategy will be facilitated by the rules, regulations, and guidances that authorize FDA to require electronic standardized data in regulatory submissions. Supported by a data standards governance, the strategy’s key data standards goals and objectives fall into the following areas: pre-market review, post-market safety, and pharmaceutical quality.
    The session will present the joint strategy, action plan, and updates such as SDTM / ADaM / SEND, therapeutic area standards, technical rejection of submissions, IDMP, and ICSRs. In addition, updates on the technical conformance guides and other technical specifications will be presented.

    This session will provide updates on the data standards in development, supported and required and have an impact on sponsor's electronic submissions to the FDA.
    Learning Objective : Explain the key data standards and impact on industry; Describe the key points of the FDA data standards strategy; Demonstrate an understanding of the data standards action plan and its projects.
    Speaker(s)
      Mary Ann  Slack

      CDER Perspective

      Mary Ann Slack

      • Deputy Director, Office of Strategic Programs, CDER
      • FDA, United States
      Representative Invited

      CBER Perspective

      Representative Invited

      • FDA, United States