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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)

Betsy  Fallen, RN

Betsy Fallen, RN

Consultant

BAFallen Consulting LLC, United States

Speaker(s)

Radius  Davenport, PhD

Office of Scientific Investigations - Bioresearch Monitoring (BIMO) Selection of Clinical Sites for Inspection - Sponsor Perspective

Radius Davenport, PhD

Radius Health, United States

Vice President Regulatory Affairs

Nate  Freimark

CDISC Perspective

Nate Freimark

Theorem Clinical Research, United States

Senior Director, Biometrics Operating Standards Group

Jean M. Mulinde, MD

FDA Update on CDER’s Clinical Investigator Site Selection Tool

Jean M. Mulinde, MD

FDA, United States

Associate Director, Division of Clinical Compliance Evaluation, OSI

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