Understand the role of a medical products regulatory affairs specialist and the dynamic nature of the regulatory field. Study the regulatory jurisdiction of the U.S. Food and Drug Administration.
Learn the laws and regulations that apply to the development, testing and production of medical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices. Explore post-market issues and requirements such as inspections, reporting and enforcement.
- Option to take for noncredit CEUs or for graduate credit that can be applied to the Master of Science in Biomedical Regulatory Affairs
- Class field trips to local companies to learn about Good Manufacturing Processes
- Optional participation in a special group project that involves conducting a structured policy analysis of an existing law, statute or regulation
Who Should Apply
- Individuals who seek to expanded their understanding of regulatory affairs for the drug and medical device industry
- Individuals who want to enter or advance in the biomedical regulatory affairs field