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Session 4: New FDA Draft Guidance on Part 11 in Clinical Investigations and Mobile Technologies in Clinical Investigations

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

      Ron D. Fitzmartin, PhD, MBA

      • Senior Advisor, Office of Strategic Programs, CDER
      • FDA, United States
    This session will review the new 2017 FDA Guidance on 21 CFR Part 11 in Clinical Investigations, the public comments, discuss next steps, and hear from the audience on the topics presented.
    Speaker(s)
      Leonard  Sacks, MD

      Regulatory Considerations in the Use of Mobile Technology in Clinical Investigations

      Leonard Sacks, MD

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

      Part 11 Guidance

      Cheryl A. Grandinetti, PharmD

      • Health Scientist, Policy Analyst
      • FDA, United States