Course Information for 5900 - Introduction to Regulatory Affairs: Combination Products
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Primary Instructor: John Skousen
Credits: 3.0
Semesters Offered:Fall
Frequency Offered:Even Years
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
Catalog Description: 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. The primary course project will focus on developing a regulatory strategy and accompanying regulatory submissions for a combination product. As part of this process we will focus on design control and clinical trials regulations that will lead to the preparation of a request for designation, clinical trial design, risk analysis, IRB and IND/IDE submissions. IRB submissions will be based on the training program between the Department of Bioengineering and the University of Utah IRB where students prepare and submit IRB applications through the University of Utah IRB training portal.
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_5900.pdf