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
Principal, Consulting Quality CoE
Director, Consulting Quality COE
Who should watch?
This content applies to anyone involved in the conduct and reporting of FDA-regulated research, on-site inspections, and data audits; compliance program managers; clinical investigators, clinical trial monitors, sponsors, and CROs.
Provider approved by the California Board of Registered Nursing, Provider Number 17600, for 1 contact hour. This documentation must be retained by the licensee for a period of 4 years after the course concludes.
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Certificate of Attendance
After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.
DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour