BTEC 612 Reg Affairs in Life Science Industr

Regulatory affairs (RA) are set of rules and regulations that oversee and govern product development as well as post-approval marketing in the life sciences. For US companies, Food and Drug Administration (FDA) establishes and oversees the applicable regulations under several statutes, partnership with legislators, patients, and customers. The commercializable products for Biotechnology sector can be food, drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA, and its effect on product development. The course will cover RA history, various regulatory agencies, methods to access regulatory information, procedures for drug submissions, biologics submissions, and medical device submissions. It will also address Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA inspections and so on. The course will include guest lectures, actual case studies and real world scenarios. As a course project, students will create a conceptual submission document for a hypothetical drug/biologic/medical device approval.