RGA 7120 — Multi-Stakeholder Perspectives in Biomedical Product Access
3 semester hoursGraduateLecture
Offers students an opportunity to develop life science product commercialization strategies from the regulator’s perspective. Explores regulatory affairs topics including preclinical and clinical safety and performance data, labeling requirements, potential long-term product effects, and manufacturing considerations. Through critical analysis of pre- and post-commercialization regulatory submissions, synthesizes the effectiveness of safety and efficacy measures to warrant approval. Considers the role of the regulator in evaluating technological advancements in personalized medicine, companion diagnostics, combination products, and other emerging product categories.