Course Information for 5110 - Introduction to Regulatory Affairs
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Primary Instructor: John Skousen
Designation:Elective
Credits: 3.0
Semesters Offered:Fall
Frequency Offered:Annual
Prerequisites:Full major status in biomedical engineering, graduate status, or instructor approval. This course DOES NOT require Introduction to Regulatory Affairs: Medical Devices as a Prerequisite.
Class Schedule: Lecture T & H 12:25-1:45. Lab W 11:50-1:45 or F 8:35-10:35
Catalog Description: Biomedical Engineering, especially the development of medical devices, drugs, biologics, 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 is a hands-on regulatory affairs course that will give students a solid foundation and understanding of the regulation of medical devices, drugs, biologics, and combination products in US. The course consists of both a lecture and laboratory component. Lectures will cover the fundamentals of US regulatory affairs. The laboratory session will focus on practical implementation of the material covered in the lectures by developing regulatory strategies and preparing elements of regulatory submissions for assigned projects. Students will work in teams and will focus on developing a regulatory strategy and selected regulatory submissions for an assigned regulated product, such as a medical device or a combination product. For example, the elements of regulatory submissions may include the preparation of requests for designation/classification, preclinical and clinical trial design, risk analysis, REMS, IND/IDE submissions, and response to a warning letter from FDA.
Optional Texts:Recommended reading material will be announced in class and will be posted on CANVAS.
Course Website: Course is adminstered via Canvas
Course Syllabus:Syllabus_5110.pdf