LAW589A

040675

This course provides students with essential knowledge of the regulations governing medical product development and approval processes. Students explore the multifaceted challenges confronting industry and regulatory decision-makers, while examining how federal agencies shape therapeutic innovation to improve safety, efficacy, quality, and performance of pharmaceuticals. Students will study the organizational structure, statutory authority, and operational functions of key regulatory agencies, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Students will also become familiar with frameworks governing public-private partnerships and their impact on clinical trial design. Through a combination of foundational concepts and real-world case studies, students develop and apply strategies necessary for navigating complex regulatory landscapes in the pharmaceutical and biotechnology industries.

GRD - Regular Plus/Minus Grades A, B, C, D, E

Law