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Regulatory Submissions, Information, and Document Management Forum


Session 2: FDA Opening Plenary Panel: PDUFA VI Informatics

    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
    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. In addition, receive an update on the CBER-CDER Joint Data Standards Strategy and Action Plan, and the Public Meeting scheduled for March 2018.
    Speaker(s)
      La Misha  Fields

      Electronic Submissions Gateway Update

      La Misha Fields

      • IT Program Manager, Electronic Submissions Gateway, OIMT, OC
      • FDA, United States
      Virginia  Hussong

      Data Standards Strategy and Action Plan Update

      Virginia Hussong

      • Chief, Data Standards Program, CBER
      • FDA, United States
      Ethan  Chen, MBA

      Electronic Submissions Update

      Ethan Chen, MBA

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