PHRMSCI X481

Post-Approval Compliance Requirements for Pharmaceutical Products

A required course in the Certificate Program Regulatory Affairs and Compliance.

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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Course
Approximate Cost $620
Format Online
Duration 7 Weeks
Total Credits 2

WINTER 2024

1/8/2024 - 2/25/2024
Weeks 7
Delivery Online
Fee $620
Status Closed

SUMMER 2024

6/24/2024 - 8/11/2024
Weeks 7
Delivery Online
Fee $700
Status Open