Clinical Trials Regulation & Conduct

0.5 Credit Hour

The course will explore the intersection of law, ethics, and medicine, providing students with a comprehensive understanding of the rules, principles, and guidelines that ensure the ethical and legal conduct of clinical trials. We’ll then dive further into exploring how pharmaceutical and biotech companies navigate regulatory pathways to build successful clinical development strategies and design clinical trials that ultimately result in product approvals. Students will learn about the various stakeholders, including institutional review boards, biosafety committees, regulatory agencies, pharmaceutical/biotechnology companies, and researchers.