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2024 Combo Products Summit Agenda

session

The EU COMBINE Project: Medical Devices and IVDs Used in Medicinal Product Studies

October 10, 2024 @ 9:10 am

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10:10 am

Moderator

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Speakers

Isabelle Clamou, Policy Officer, European Commission
Olga Tkachenko, Policy Officer, European Commission

In the European Union, clinical trials for medicinal products, clinical investigations of medical devices, and performance studies of in vitro diagnostics (IVDs) are governed by separate regulations and approved through separate pathways. Sponsors wishing to investigate these products within the same investigational protocol (combined studies) face regulatory and operational complexities to remain in compliance with each clinical trial approval pathway. Competent authorities have recently started the COMBINE Project, which aims to analyze the root causes of the challenges encountered by sponsors in conducting combined studies and to identify possible solutions for these challenges.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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