戻る Agenda
Regulatory and Industry Perspectives on the Common Protocol Template
Session Chair(s)
Robert DiCicco, PharmD
Vice President, Portfolio Management, 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
Speaker(s)
Industry Perspective
Kenneth Getz, MBA
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
FDA Perspective
Vaishali Popat, MD, MPH
Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
NIH-FDA Protocol Template and the Benefits of Having a Common Protocol Template for Phase 2 and 3 Trials
Cynthia Boucher, MS
Clinical Trials Specialist, National Institutes of Health (NIH), United States