Considerations In Combination Product Risk Management

By Susan Neadle, Johnson & Johnson, Inc.; Jennifer L. Riter, West Pharmaceutical Services, Inc.; T. Page McAndrew, West Pharmaceutical Services, Inc.

Drug-device combination products are an ever-increasing presence in the pharmaceutical landscape. Benefits include more convenience for patients, lower costs from fewer/eliminated hospital/clinic visits, fewer steps in usage as drug product may not need to be withdrawn from a vial, better safety with automatic needle retraction, and better compliance through connectivity such as smartphone apps. As with any pharmaceutical product, commercial offering requires demonstration of performance and compliance with applicable regulations.

This article is a review of select aspects of the webinar, "Creating an Effective Combination Products Risk Management Program: Special Considerations for Control and Analytical Testing Strategies Development."