RGA 7110 — Biomedical Product Post-Market Regulatory Strategy

3 semester hoursGraduateLecture

Offers students an opportunity to develop perspectives on life science product post-commercialization strategic activities in the U.S. market. Focuses on key stakeholder trends in the formulation and implementation of successful post-commercialization regulatory strategies and submissions. Explores the development of post-market surveillance strategies, adverse event reporting requirements, and regulatory strategies to monitor manufacturing of commercialized pharmaceutical, biologic, and medical device products. Reviews the evolving nature of advertising and promotional regulation given the rapid advance in social media technologies.

Links

Official catalog (RGA course descriptions) · All RGA courses · Plan it at numap.app