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Combination Products
Session Chair(s)
Sabina Hoekstra-van den Bosch, PharmD, MSc, RPh
Global Director Regulatory Strategy, Tüv Süd, Netherlands
Session in development
Learning Objective : Participants will learn about managing post approval changes to combination products in compliance with US 21 CFR part 4 and the upcoming EU medical devices regulations (MDR). Presentations will cover design history files, human factor and clinical studies for legacy combination products.
Speaker(s)
Gert Bos, PhD, MSc
Chief Scientific Oficer, Executive Director, Partner, Qserve Group B.V., Netherlands
Consultation in Evolution
Judite Neves, PharmD
Head of Health Products Directorate, Infarmed, Portugal
Combination in Evolution
Mike Wallenstein, MSc
Global Head MDR Implementation and DD&C Compliane, Novartis , Switzerland
Lifecycle Management of Combination Products
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