Keynote: FDA presents Recent BIMO Updates as well as GCP Inspection Trends, Metrics

Wednesday, May 17, 2023, 1:00 PM - 2:00 PM

Recent updates to the Bioresearch Monitoring Program (BIMO) for Sponsors and Contract Research Organizations shed light on FDA’s current thinking on important topics such as the selection and monitoring of clinical investigators and outsourced services.  

In this session, Dr. Cochran will discuss the updates, what this means for inspections, highlight some recent inspection findings and metrics, and discuss FDA’s focus on Risk Based Quality Management.