Post-Approval Maintenance of Drugs, Biologics, and Devices

Catalog description

Drug development is complex, time consuming, and resource intense across multiple disciplines that require subject matter expertise. The goal is to obtain FDA-approval of a marketing application, which, once achieved, is a major accomplishment. However, marketing approval brings significant Sponsor responsibilities as the FDA continues to enforce strict regulatory requirements to ensure marketed products maintain their favorable benefit/risk profiles and therefore continue to offer safe and effective options for patients. This course is designed to provide students with an in depth understanding of the multiple regulatory requirements and marketing activities that take place following FDA approval, throughout the lifecycle of a marketed product. Topics include: • Post-marketing requirements • Pharmacovigilance/safety surveillance • Manufacturing throughout product lifecycle • Device regulations • Labeling considerations • Sales, marketing, advertising, and promotional activities • FDA inspections • General lifecycle management, label expansion, patent and exclusivity considerations