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DIA 2018 Global Annual Meeting


PDUFA VI: Improving Transparency and Accountability of Electronic Submission and Data Standards Activities

    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
    FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. The PDUFA VI Section IV Information Technology goals focus on following areas: 1. Electronic Submission process from Gateway (ESG) to FDA Center, 2. Technical rejection of submissions process and validation criteria, 3. Electronic system status, performance and metrics, and 4. Data standards, adoption and conformance. This session will provide an overview of the FDA electronic submission systems and data standards that impact sponsors applications from time of submission at the ESG through the time the submission is made available to the review team.
    Learning Objective : Describe the electronic submission process including key milestones; Explain the rejection process for electronic submissions; Explain the electronic submission gateway submission upload timeframes and notifications to sponsors; Discuss the data standards catalog and action for industry.
    Speaker(s)
      Representative Invited

      FDA Update

      Representative Invited

      • FDA, United States
      Representative Invited

      FDA Update

      Representative Invited

      • FDA, United States
      Ethan  Chen, MBA

      FDA Update

      Ethan Chen, MBA

      • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
      • FDA, United States