Intellectual Property, Regulation, and Quality Assurance

Catalog description

This course comprises the study of fundamental topics of intellectual property (IP), such as patents, copyright and related rights, and trademarks. 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. The quality portion of the course is focused on FDA Quality System Regulation (QSR) framework and requirements. These topics will be analyzed with a focus on safety, surveillance, business, law, and procedures surrounding the regulations in the health care industry. Students will be prepared to work within regulatory and quality assurance constraints necessary for development of medical products, drug manufacturing, and clinical investigations.