Next Start Date
September 2023
Learn the key aspects of taking a medical product — drug, device or biologic — from concept to market, including clinical trials and post-marketing surveillance. Improve your technical writing skills and gain hands-on experience shepherding a product through regulatory review, clinical trials and quality assurance.
For more information, see the UW Master's in Biomedical Regulatory Affairs website.
Learn how to write regulatory documents and summarize clinical trial data. Gain experience crafting documents for regulatory submission and become familiar with the prescribed formats.
Develop a thorough understanding of the fundamental concepts, principles and skills that guide the design and implementation of different types of clinical trials.
Learn about the role of regulatory affairs specialists in the dynamic world of medical product development. Explore the regulatory jurisdiction of the U.S. Food and Drug Administration.
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