Clinical Investigations for Combined Use Systems

Thursday, November 13, 2025

11:25 AM - 12:25 PM East Coast USA Time

Location: Narragansett Ballroom

Moderator(s)

Tine Schroder-Albeck

Associate Director - Head of Device Development and Support
ALK A/S
Ryan McGowan

Senior Director, Devices and Digital Therapeutics
AstraZeneca

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Speaker(s)

Tim Chesworth (he/him/his)

Global Head, Medical Device Regulatory Affairs
Novartis
Ditte Zerlang Andersen (Virtual)

Senior Program Manager, Medicines Licensing & Pharmacovigilance
Danish Medicines Agency

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.