Pharma Clinical, Regulatory, and Compliance

Learn about Pharma Clinical, Regulatory, and Compliance

This course provides an in-depth understanding of the clinical trial process, regulatory requirements, and compliance issues in the pharmaceutical industry. Students will learn about the phases of clinical trials, including the design, conduct, and analysis of clinical trials, and the ethical considerations in human subjects’ research. Additionally, students will gain an understanding of the regulatory framework for drug development, including the role of the FDA and other regulatory bodies, and the submission and review process for new drug applications. The course will also cover compliance issues, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP), and the importance of ensuring regulatory compliance throughout the drug development process.

Note: This new course is scheduled to launch in Spring 2025. 

Course Number: BIOL-40381
Credit: 3.00 unit(s)
Related Certificate Programs: Drug Discovery and Development