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DIA 2018 Global Annual Meeting

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

Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection

    Session Chair(s)
      Wayne  Amchin, MA, MPA, RAC

      Wayne Amchin, MA, MPA, RAC

      • Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER
      • FDA, United States
    This session will explore select endpoints FDA has already accepted in traditional clinical trials but which are now collectable using mobile technology in lieu of traditional means to obtain marketing approval, and the timing/options to engage FDA.
    Learning Objective : Describe select endpoints FDA has already accepted in traditional clinical trials which may lend themselves to data collection using digital/mobile technology in clinical trials for marketing approval; Evaluate the challenges faced in adapting these endpoints to use of mobile technology; Apply this information to engage with the FDA early in your product development; Discuss the challenges.
      Mintu  Turakhia, MD, MS

      Clinical Trials Using Mobile Technology

      Mintu Turakhia, MD, MS

      • Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA
      • Stanford University , United States
      Bakul  Patel, MD

      FDA Perspective

      Bakul Patel, MD

      • Associate Director for Digital Health, Office of the Center Director, CDRH
      • FDA, United States
      Stephen  Amato, PhD

      Industry Perspective

      Stephen Amato, PhD

      • Project Manager for Digital Innovation
      • Pfizer Inc, United States