Post-Approval Activities

This course provides a comprehensive overview of post-approval regulatory affairs for biopharmaceutical products, with a focus on regulatory compliance following product licensure and commercialization. Students will learn how regulatory professionals collaborate with cross-functional teams and interface with agencies such as the U.S. Food and Drug Administration to support ongoing regulatory obligations throughout the post-market lifecycle. The curriculum covers key post-market requirements, including Phase 4 studies, pharmacovigilance and safety surveillance, labeling updates, supplemental regulatory submissions such as sNDA and sBLA, and ongoing compliance strategy. Learners will gain practical skills in managing Prior Approval Supplements, CBE-30 submissions, annual reports, field alerts, recalls, regulatory documentation, and post-market compliance processes that support product safety and regulatory readiness. This course prepares students for careers in regulatory affairs, pharmacovigilance, drug safety, quality compliance, and post-market regulatory strategy within the pharmaceutical and biotechnology industries.