BTEC 612 - Regulatory Affairs in Life Science Industries

(3 semester hours)
Prerequisites: Bachelor of Science degree in Biotechnology, Life Science or other relevant field or by permission of instructor
Description: Regulatory affairs (RA) are rules and regulations that oversee and govern product development and post-approval marketing in the life sciences. For US companies, Food and Drug Administration (FDA) establishes and oversees the applicable regulations under several statutes, partnerships with legislators, patients, and customers. The commercializable products for the 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 covers RA history, various regulatory agencies, methods to access regulatory information, procedures for drug submissions, biologics submissions, and medical device submissions. It also addresses Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA inspections. The course includes guest lectures, actual case studies and real world scenarios. As a course project, the student creates a conceptual submission document for a hypothetical drug/biologic/medical device approval.