BMSC 5320 Introduction to Regulatory Affairs

3 SCH. This course provides students with in-depth knowledge of the therapeutic development and regulation process from preclinical testing through post-marketing adverse experience reporting and will offer students an opportunity to conduct a comprehensive and up-to-date analysis of the complete U.S. pharmaceutical and biological products approval processes. It also considers FDA standards for nonclinical testing-quality assurance issues and good laboratory practice, investigational new drug (IND) applications, therapeutic market applications and review process initiatives designed to speed therapeutic product review, as well as current good manufacturing practice regulations to assure quality of marketed products.
Prerequisite: Course restricted to Clinical Research Management majors of have department consent.
Offered Summer
Letter Grade