Course Information for 5900-002 - Introduction to Regulatory Affairs: Medical Devices
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Primary Instructor: Tomasz Petelenz
Designation:Elective
Credits: 3.0
Semesters Offered:Fall
Frequency Offered:Odd Years
Prerequisites:Bioengineering Major or Bioengineering Graduate Status
Class Schedule: T, Th 12:25 – 1:45pm, Lab T 2:00-5:00
Catalog Description: This is first in a 2-semester regulatory affairs course focusing on the general framework of the US and global regulatory systems. Special emphasis will be placed on medical devices and combination products. The course will stress practical, hands-on project–based learning by introducing laboratory and workshop-type activities, analysis of real-world case studies, preparation of mock- and actual regulatory submissions, communication with the FDA reviewers, and interaction with design teams from local companies. Overall this course will help students practice the skills and knowledge of applying regulations and FDA guidances in order to develop regulatory strategies for real world products.
Optional Texts:Text (Optional): Fundamental of US Regulatory Affairs 8th ed.
Course Syllabus:none