Featuring Commander Gene Gunn, MSPH.
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).
9:50 am
Main Stage
Nov 5
Featuring Commander Gene Gunn, MSPH.
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).