RGA 7100 — Regulatory Frameworks for Biomedical Product Development
3 semester hoursGraduateLecture
Offers students an opportunity to develop perspectives on strategic activities for the pre-commercialization of life science products in the United States. Focuses on stakeholder trends in the formulation and implementation of successful pre-commercialization regulatory strategies and submissions. Explores regulatory activities, including GLP requirements for the development of drug and biologic products and QSR requirements for the development of medical device design. Discusses the emerging paradigm of convergence between regulatory and reimbursement requirements, as well as life science product cost-effectiveness and health technology assessments. Incorporates case study analyses to evaluate the importance of including the most recent market access variables into the formulation of regulatory strategies.