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2016 年 02 月 08 日 12:00 下午 - 2016 年 02 月 10 日 5:15 下午

Regulatory Submissions, Information, and Document Management Forum

Session Chair(s)

Stacy  Tegan

Stacy Tegan

Program Director

Transcelerate Biopharma, Inc., United States

Speaker(s)

Ron  Fitzmartin, PhD, MBA

FDA Perspective of the Protocol Template

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Informatics 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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