A UL course
This course provides an overview and historical perspective of the Bioresearch Monitoring (BIMO) program directed by the US Food and Drug Administration (FDA). The course covers methods and techniques used in conducting and reporting nonclinical laboratory, clinical investigator, institutional review board, sponsor/monitor, and in-vivo bioequivalence inspections.
- Evolution of FDA regulatory history
- BIMO terminology
- The purpose, regulations, and expectations of BIMO
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields