Drug/device combination products represent the next wave of drug delivery devices of increasing complexity. Their development requires the number of ..
technical challenges to consider - integrating drug and device systems, defining the elements of design control, determining quality systems and manufacturing processes. It is also critical to establish a regulatory and clinical strategy from early on in development. Our meeting facilitates a better understanding of both regulatory and practical aspects of developing drug-device combinations, as well as the management of combination products across the total product life cycle.
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