Planning For Success: Navigating Regulatory Strategy And Design Verification For Combination Products

The market for injectable drugs has seen steady growth in the last ten years, and forecasts suggest this strong upward trend will continue. Several factors contribute to this, notably the rising number of annual drug approvals and the booming biologics industry. Likewise, the combination product market has grown substantially. This surge is driven by the increasing occurrence of long-term illnesses, the desire for therapies patients can administer themselves, the appeal of less invasive treatments, and progress in technology.

The regulatory environment for creating combination products is evolving, with regulatory bodies now having significant knowledge in this field. As a result, it's expected that companies developing combination products must have a deep understanding of both the drug and device components. They also need to understand how these elements work together and the performance of critical system parts when combined.

This webinar explores the complexities of combination products and how to get them approved by regulatory agencies. Review what regulators expect in combination product submissions, highlighting risk-based methods for determining, evaluating, and documenting performance requirements. Learn more about Design Verification strategy and real-world examples of developing and validating physical test methods to evaluate device performance.