On-Demand 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. 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

Presented By

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Joan Versaggi

MBA

Principal, Consulting Quality CoE
Advarra

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Leslie Paul

MS

Director, Consulting Quality COE
Advarra

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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.

CE Credits

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.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

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

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