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CLINICAL, QUALITY & REGISTRATION CONSIDERATIONS FOR BIOLOGICS COMBINATION PRODUCTS DEVELOPMENT
Session Chair(s)
Paul Jansen
Asssociate Vice President Medical Device Development
Sanofi, United States
EU/US Registration dossier challenges for biologics/device combinations
Learning Objective : This presentation will provide the audience with key considerations for PreFilled Syringes and Pen Injectors as drug delivery systems (DDS) for biologics, including human factors aspects. The audience will gain an overview of which quality attributes of these DDS may impact the drug safety and efficacy, where and how best integrating these data in Module 3 for EU and US applications
Speaker(s)
The EU Framework for Combination Products – A Regulatory View
Christa Wirthumer-Hoche, PhD
Austrian Medicines & Medical Devices Agency (AGES), Austria
Chair, EMA Management Board, Head
EU/US Registration dossier challenges for biologics/device combinations
Marielle Fournier, PharmD
Voisin Consulting Life Sciences, France
Senior Director, Medical Devices and Combination Products
Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products
Marina Alexandra Malikova, PhD, MBA, MS, RAC
Boston University School of Medicine, United States
Executive Director, Translational Research, Assistant Professor of Surgery
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