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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 1 Track 3 - Mission Possible: How TransCelerate is Improving the Protocol Template and Paving the way for the Digital Protocol

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

TransCelerate BioPharma, a non-profit consortium of over 20 sponsor companies, is tackling some of the biggest challenges in the clinical development process. The Common Protocol Template, and a implementation communications toolset, is now available to anyone via the TransCelerate website. Learn how this protocol template brings value today and sets the stage for enabling trial registry disclosure, downstream automation, and end-to-end traceability.


Ron  Fitzmartin, PhD, MBA

FDA Perspective of the Protocol Template

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Advisor, Office of Regulatory Operations, CBER

Robert  DiCicco, PharmD

The Common Protocol Template: Common Structure, Common Language, Uncommon Benefits to End Users

Robert DiCicco, PharmD

TransCelerate Biopharma Inc., United States

Vice President, Portfolio Management

Robert L. Ferendo

The Common Protocol Template: Foundation for the Future

Robert L. Ferendo

Eli Lilly and Company, United States

Consultant-Process & Technology

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