ABMS 5315. Pharmaceutical & Biotechnology Regulatory Science. 3 Hours.
Students examine the regulatory landscape of the pharmaceutical and biotechnology industries with a focus on the scientific principles guiding regulatory practices. Topics may include regulatory frameworks for pharmaceutical drugs, biologics, gene therapies, and biosimilars, as well as preclinical research, clinical development phases, regulatory filings, and Biologic License Applications (BLAs). Students evaluate challenges faced by biotechnology companies in meeting FDA and international regulatory standards. Students also analyze emerging trends such as orphan drug development, personalized medicine, and global regulatory harmonization.
Prerequisite: ABMS 5301, ABMS 5302, ABMS 5303 & ABMS 5304.
