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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, MBA

FDA Perspective of the Protocol Template

Ron Fitzmartin, MBA

Principal Consultant, Decision Analytics, United States

Robert  DiCicco, PharmD

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

Robert DiCicco, PharmD

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States

Robert L. Ferendo

The Common Protocol Template: Foundation for the Future

Robert L. Ferendo

Consultant-Process & Technology, Eli Lilly and Company, United States

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