BIMO: US FDA's BIMO Compliance Program
This 2-part course covers the significant events that led up to the creation of the Bioresearch Monitoring Program at US FDA, as well as its organizational structure, how the BIMO inspections are assigned, managed, and followed up.
After taking this course the learner will be able to successfully:
- Anticipate the reasons prompt FDA to conduct an audit of a clinical investigation and,
- understand the current issues and enhancements that are affecting the BIMO program.
Clinical project managers, senior Clinical Research Associates, data managers, biostatisticians, Clinical quality managers and quality managers involved in the audits and quality systems of clinical investigations for medical devices.
Regulatory managers likely to deal with FDA inspections.
Clinical investigators and study coordinators involved in medical device clinical investigations.
Have a full understanding of good clinical practices and all processes involved in a clinical investigation starting with all aspects explained in Effective Monitoring of Medical Device Clinical investigations (ID 57), US FDA Investigational Device Exemption IDE Overview (ID 121), and preferably have knowledge and experience in clinical project management (ID 95).It is highly recommended to take this course in conjunction with the suite of courses on Auditing Medical Device Clinical investigations (ID 216).