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In the near future, applications for new drug status will be submitted to the FDA. As a part of the approval process, sponsors and clinical investigator sites can expect to be inspected by investigators from the USFDA’s Bioresearch Monitoring (BIMO) program. This presentation will explain the inspection process and how sponsors and study sites should be using Good Clinical Practices (GCPs) to protect the rights of human study subjects while generating high quality data to support their New Drug Applications (NDAs).

Details

  • Main Stage
Date:
11/05/2022
Start Time:
9:50 am
End Time:
10:35

Commander Gene Gunn, MSPH

Bioresearch Monitoring Specialist, FDA and US Public Health Service

CDR 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 current…

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