BME I6100 Intellectual Property, Regulation and Quality Assurance

This course comprises the study of fundamental topics of intellectual property (IP), such as copyright and related rights, trademarks, and patents. Contemporary issues of the IP field, including unfair competition, enforcement of IP rights and emerging issues in IP are also discussed. Regulation of pharmaceutical drugs and medical devices will cover applicable laws and regulations in the strategic planning, development, manufacture and commercialization of health care products. These topics will be analyzed with a focus on safety, surveillance, business, law, and international procedures surrounding the regulations in the health care industry. Students will be prepared to work within regulatory and quality assurance constrains necessary for development of medical products, drug manufacturing, and clinical investigations.

Credits

3

Contact Hours

3 hr./wk.