ABMSÂ 5303. Principles of Clinical & Biomedical Regulations. 3 Hours.
Students gain an overview of key regulatory frameworks, including patient privacy laws, drug and device approval pathways, and global data protection standards. They examine the roles of regulatory agencies, the fundamentals of compliance, and the processes that shape clinical research and medical practice. Topics may include informed consent, clinical trial oversight, healthcare disparities, and the ethical and regulatory challenges posed by emerging technologies such as artificial intelligence. Through case studies and policy analysis, students develop a working knowledge of how regulatory science influences modern healthcare systems and drives biomedical innovation. Credit: 3 hours.
