返回 Agenda
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)
Consultation in Evolution
Gert Bos, PHD, MSC
Qserve Group B.V., Netherlands
Chief Scientific Oficer, Executive Director, Partner
Combination in Evolution
Judite Neves, PHARMD
Infarmed, Portugal
Head of Health Products Directorate
Lifecycle Management of Combination Products
Mike Wallenstein, MSC
Novartis , Switzerland
Global Head MDR Implementation and DD&C Compliane