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. The agency recently updated the compliance program governing inspections of sponsors and CROs. This may mean operational resets for sponsors and CROs, 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.

Attendees will learn:

  • How recent BIMO changes impact governance – inclusive of vendor management and oversight
  • What companies should have in place to prepare for regulatory inspections
  • What to expect and best practices for hosting a sponsor/CRO inspection

Register for the on-demand webinar