Master of Science in Quality Assurance and Regulatory Science
QARS 460-0
( Elective ) Drug and Biologics Regulations
Students discuss current policies and guidelines under which pharmaceutical and biological products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Students examine the newly implemented steps to harmonize international regulations. Prerequisite: QARS 401 or CLIN_RES 400. This class may be taken as an elective for MCRRA.