Clinical Investigations for Combined Use Systems

Clinical investigations of combined use product scenarios, such as cross-labeled or co-packaged medicine delivery systems or medical devices used for data collection in medicine studies, are associated with complex investigational approval pathways in some global regions. This session will provide an overview of global requirements for combined use studies and will provide an update of the European Commission’s COMBINE project, which is intended to simplify clinical investigations including medicinal products, medical devices, and in-vitro diagnostics.