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DIA 2018 Global Annual Meeting

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

Regulatory and Industry Perspectives on the Common Protocol Template

    Session Chair(s)
      Robert A. DiCicco, PharmD

      Robert A. DiCicco, PharmD

      • Executive Consultant
      • TransCelerate Biopharma Inc., United States
    Protocols are critical components of a medical product development program. Having a standard format and structure, as well as content from CDISC therapeutic area standards will allow sponsors and regulatory agencies be able to find the same information in the same location and it will mean the same thing.

    This session will provide an update on the regulatory and industry perspectives on the benefits/challenges of a common protocol template for regulated global clinical trials and progress toward its adoption and maintenance.
    Learning Objective : Describe the benefits of a common protocol template for industry and regulatory agencies; Recognize the challenges of a common protocol template multi-regional clinical trials; Explain the progress toward the use and maintenance of a common protocol template
      Kenneth A. Getz, DIAFellow, MBA

      Industry Perspective

      Kenneth A. Getz, DIAFellow, MBA

      • Director of Sponsored Research Programs and Associate Professor
      • Center For the Study of Drug Development, Tufts University School of Medicine, United States
      Vaishali  Popat, MD, MPH

      FDA Perspective

      Vaishali Popat, MD, MPH

      • Associate Director of Biomedical Informatics and Reg Review Science, OND, CDER
      • FDA, United States
      Cynthia  Boucher

      NIH-FDA Protocol Template and the Benefits of Having a Common Protocol Template for Phase 2 and 3 Trials

      Cynthia Boucher

      • Clinical Trials Specialist
      • National Institutes of Health (NIH), United States
      Representative Invited


      Representative Invited

      • Health Canada, Canada