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Regulatory Submissions, Information, and Document Management Forum


Session 5: FDA Ask the Regulators: Part I

    Session Chair(s)
      Virginia  Hussong

      Virginia Hussong

      • Chief, Data Standards Program, CBER
      • FDA, United States
    Session 5: FDA Ask the Regulators: Part I
    Speaker(s)
      Ron D. Fitzmartin, DIAFellow, PhD, MBA

      Speaker

      Ron D. Fitzmartin, DIAFellow, PhD, MBA

      • Senior Advisor, Office of Strategic Programs, CDER
      • FDA, United States
      Mark A. Gray

      Speaker

      Mark A. Gray

      • Senior Project Manager, BSS, CBER
      • FDA, United States
      Ethan  Chen, MBA

      Speaker

      Ethan Chen, MBA

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

      Speaker

      Leonard Sacks, MD

      • Associate Director for Clinical Methodology, Office of Medical Policy, CDER
      • FDA, United States
      Cheryl A. Grandinetti, PharmD

      Speaker

      Cheryl A. Grandinetti, PharmD

      • Health Scientist, Policy Analyst, OSI, OC, CDER
      • FDA, United States
      La Misha  Fields

      Speaker

      La Misha Fields

      • IT Program Manager, Electronic Submissions Gateway, OIMT, OC
      • FDA, United States
      Jean M. Mulinde, MD

      Speaker

      Jean M. Mulinde, MD

      • Senior Policy Advisor, Office of Scientific Investigations, OC, CDER
      • FDA, United States