Post-Approval Compliance Requirements for Pharmaceutical Products

A required course in the Regulatory Affairs & Compliance for Pharmaceuticals Certificate Program.

Product approval is a crucial milestone in a product’s lifecycle, after which, the marketing phase begins and post-approval compliance requirements commence. This course explores the FDA regulatory requirements for drugs and biologics following product approval. Some of the areas covered include promotional labeling and advertising, post-marketing surveillance (e.g., adverse events, recalls), post-marketing commitments, post-approval manufacturing changes, post-approval submissions to the NDA/BLA, supply chain management, and quality systems, including compliance with 21 CFR 11 governing electronic records. Students who complete this course will be equipped with relevant knowledge and skills needed to meet post-approval regulatory requirements.

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