Regulatory Issues in Pharma

Catalog description

Regulatory Issues in Pharma (Drug Discovery and Development) course provides an in-depth examination of the regulatory, legal, and ethical landscape governing modern pharmaceutical research and development, with particular emphasis on advanced modalities such as cell and gene therapies. This course is ideal for students interested in careers in pharmaceutical and biotech R&D, regulatory affairs, translational science, or pre‑professional health and biomedical graduate programs. Student will bridge fundamental skills learned with how this translates in regulatory guidelines and approvals. Students will learn how regulatory frameworks shape decision-making from target identification and preclinical testing through clinical trials, marketing authorization, and post‑marketing surveillance in the United States and globally.