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Session 4 - Novel Clinical Trial Approaches
Session Chair(s)
Mary Parks, MD
Director, Div. of Endocrinology and Metabolism Prod., ODE II, CDER
FDA, United States
NOVEL CLINICAL TRIAL APPROACHES
Speaker(s)
ALTERNATE CLINICAL STUDY APPROACHES TO A CV OUTCOME SAFETY STUDY
David G. Orloff, MD
Medpace, Inc., United States
Executive Director, Regulatory Affairs
THE USE OF HIGHER RISK CLINICAL POPULATIONS – DEFINITIONS AND STRATEGIES
Robert J. Temple, MD
FDA, United States
Senior Advisor for Clinical Science, OCD and Immediate Office, OND, CDER
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