BME 5120 - Regulatory Affairs II

Biomedical Engineering, especially the development of drugs, biologics, medical devices, and combination products is highly regulated by US FDA and other regulatory agencies around the globe. Succeeding in the biomedical industry requires both a good understanding of current regulations and the ability to apply them in a realistic practical environment. There is a strong demand in industry for graduates with practical knowledge of regulatory affairs. This course is the 2nd of the Department of Bioengineering’s hands-on regulatory affairs curriculum. This course is a standalone course and does not require Regulatory Affairs I as a prerequisite. This semester will place special emphasis on the regulation of drugs, biologics, and combination products. This semester also will provide an overview of international regulatory affairs.