BME 448Regulatory Affairs
This course provides an overview of the FDA regulatory process for drug, biologics, and device development. Through course work and class based discussion, students will have an opportunity to develop the foundations necessary to build a strong understanding of regulatory affairs. Topics include the historical perspective the development of U.S. drug laws, law vs. regulation, FDA and industry functions, drug, biologics and device approvals, Good Laboratory/Manufacturing/Clinical Practice and global regulatory frameworks. The class utilizes collaborative group work and case study based learning exercises.