Clinical Research Compliance

Catalog description

This course serves as an introduction to the growing area of health law known as "life sciences". The theme for this course centers on the research and development of pharmaceutical drugs and devices and the role of the FDA in regulating this process. Topics covered will include genomics, personalized medicine, the FCPA, basic patent and intellectual property issues, and financing. Students will learn to analyze the FDA approval process (LLM only or with permission.)