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Preparing for inspections of trial sites by the FDA

Commander Gene Gunn

Commander Gunn is an officer in the United States Public Health Service and serves as an FDA Investigator with the Bioresearch Monitoring program. He has been with the FDA and USPHS for 13 years and currently serves as a Specialist on the BIMO Foreign Cadre where he conducts international inspections of drug, biologic, and device trial sponsors and study sites. Prior to this he worked in a variety of roles in laboratory and clinical research as a study coordinator, IRB member, and owner of a site management organization.

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