Intellectual Property, Regulatory Concepts and Product Development. 3 credits

Catalog description

The course provides an understanding of i) intellectual property focusing on patents and the patent process in the US and globally, ii) regulatory frameworks for product approval such as FDA and international regulations, standards (ANSI, ASTM, ISO, GCP, GLP) and iii) product development including ideation and concept development, quality systems, global business models, financing and transactions. An overarching team project will involve invention, proof of concept, patenting, regulatory pathways and product development to market in a global context. Offered by Bioengineering . May not be repeated for credit.