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Session Chair(s)
Betsy Fallen, RN
Consultant, BAFallen Consulting LLC, United States
Speaker(s)
Office of Scientific Investigations - Bioresearch Monitoring (BIMO) Selection of Clinical Sites for Inspection - Sponsor Perspective
Colleen Davenport, PhD
Vice President Regulatory Affairs, Radius Health, United States
CDISC Perspective
Nate Freimark
Senior Director, Biometrics Operating Standards Group, Theorem Clinical Research, United States
FDA Update on CDER’s Clinical Investigator Site Selection Tool
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI, FDA, United States