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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

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

    Session Chair(s)
      Pujita  Vaidya, MPH

      Pujita Vaidya, MPH

      • Acting Director, Decision Support and Analysis Team, OSP, CDER
      • 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.
      Andrea  Furia-Helms, MPH

      How FDA Involves Patients and Advocates

      Andrea Furia-Helms, MPH

      • Patient Representative Program, Office of Health and Constituent Affairs, OC
      • 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  Mullin, PhD


      Theresa Mullin, PhD

      • Associate Director for Strategic Initiatives, CDER
      • FDA, United States
      Anindita  Saha


      Anindita Saha

      • Director, External Expertise and Partnerships, OCD, CDRH
      • FDA, United States
      Telba  Irony, PhD


      Telba Irony, PhD

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