(Webinar) FDA Update: BIMO – What Sponsors Need to Know
The FDA’s Bioresearch Monitoring (BIMO) program is implemented to ensure the protection of the rights, safety, and welfare of human research subjects and to ensure the accuracy and reliability of clinical trial data. The FDA’s Office of Regulatory Affairs (ORA) Office of Bioresearch Monitoring conducts inspections related to FDA regulated research. Recent updates to the compliance program governing inspections of sponsors and CROs. may mean operational resets as well as prompt the need to update inspection readiness programs. This webinar will highlight key changes to the compliance program for sponsors and CROs and provide recommended best practices for inspection readiness programs.