Device – Drug Combination Products.

Catalog description

This course focuses on defining Drug/Drug and Drug/Device combination products, regulatory requirements, design control requirements and practices in the development of Drug/Device combination products. Discussions will include regulatory guidelines, design control requirements as they apply to Drug/Device combination products, case studies, quality and GMP requirements and dossier preparation and life cycle management related aspects. Current regulations and practices will be discussed and utilized to provide students with experience in executing design control activities for a range of products. This is a hybrid course (>50% online) with distance-learning lectures and Canvas assignments. Prerequisites: Graduate student standing in the PCSP program or permission by instructor.