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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Investigator training: A three-day training course for clinical investigators on scientific, ethical and regulatory aspects of trials will be held Nov. 16-18 in Silver Spring, Md. (1"The Gray Sheet" May 11, 2009). The event is co-sponsored by FDA and the FDA/Duke University Clinical Trials Transformation Initiative. Participants must register at 2 by Nov. 2. Rachel Behrman, director of FDA's Office of Critical Path Programs, will run a session on FDA regulations and investigators' responsibilities in clinical trials. Cardiovascular Devices Division Director Bram Zuckerman will discuss clinical trial design issues for devices. Microbiology Devices Director Sally Hojvat will discuss diagnostic and combination product trial questions, according to a preliminary 3agenda

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