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DIA 2018 Global Annual Meeting


Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision

    Session Chair(s)
      Representative Invited

      Representative Invited

      • FDA, United States
    This will discuss the FDA's history of including patient's voice in the regulatory process and current or new efforts that may be more advanced. How has their view of patient engagement changed? Evolution of the Patient Representative Program and Patient Engagement Advisory Council, for example. Engage in dialogue with the FDA and provide considerations for next steps, including from sponsor and patient.
    Learning Objective : Describe current and upcoming FDA efforts to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Discuss regulatory and methodological considerations that must be addressed in order to realize the full potential for patient input to support medical product development and evaluation.
    Speaker(s)
      Representative Invited

      How FDA Involves Patients and Advocates

      Representative Invited

      • FDA, United States
      Eleonora  Ford, PhD

      Partnering for Patients: A Regulatory Framework to Advance Patient-Focused Drug Development

      Eleonora Ford, PhD

      • Global Regulatory Affairs and Policy
      • Amgen Inc., United States
      Theresa M. Mullin, PhD

      Panelist

      Theresa M. Mullin, PhD

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

      Panelist

      Representative Invited

      • FDA, United States
      Telba  Irony, PhD

      Panelist

      Telba Irony, PhD

      • Deputy Director, Office of Biostatistics and Epidemiology, CBER
      • FDA, United States