BIOL 2078
Regulatory Affairs in Pharma, Med Device and Digital Health
Brown University · UGRD · Fall 2026
Catalog description
In a global regulatory environment, learning the process of moving a medical device, drug or biologic from conception to market can be daunting. This course will provide the framework for regulatory affairs strategic knowledge with a focus on the process from development to commercialization, and post commercialization in a global environment. This course is particularly suitable for students interested in pursuing a career within a biotechnology company, or for those interested in developing a foundational understanding of how regulatory and health authorities regulate products in order to safely and effectively bring products to patients. Preference given to Biotechnology Masters Therapeutic Science PhD.
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