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Wednesday, June 21 • 2:00pm - 3:15pm
#355: FDA, NIH, and TransCelerate Collaborate to Accelerate Drug Development Through Protocol Harmonization

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Since, 2010 the number of new studies registered in Clinical Trials.gov has increased by over 20,000 per year. These include studies sponsored by diverse groups of clinical researchers including pharmaceutical companies, investigators and NIH. All of these protocols rely on the same health care and regulatory infrastructure for design, review and implementation. Data suggest that a significant opportunity exists for an improvement in quality and simplification through protocol harmonization.

Learning Objectives

Discuss the alignment on a common protocol structure; Describe the benefits of adopting a harmonized template; Identify best practices for intended users; Discuss the impact of protocol quality and protocol complexity on health care and regulatory resource.


Robert A. DiCicco, PharmD


Vaishali Popat, MD, MPH

Michelle Culp, BSN, MPH


Michelle Culp

Director of Clinical Operations, National Center For Advancing Translational Sciences (NCATS)
Michelle Culp, BSN, MPH is the Director of Clinical Operations at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) and works for the Office of Science Policy. She is the Acting Director of the NCATS Trial Innovation Network tha... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Reg Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing d... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm
S404bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum