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Opening Plenary-Combination Products in Europe: Gaining Traction?
Session Chair(s)
Gert Bos, PhD, MSc
Chief Scientific Oficer, Executive Director, Partner
Qserve Group B.V., Netherlands
Sophie Tabutin
EMEA Regulatory Affairs Leader
W.L. Gore & Associates, France
The panel will discuss the challenges that the MDR brings specifically for combination products, whether this is the transition from MDD to MDR, the reclassification of a legacy device as a combination product under MDR, and the challenges of Article 117. Panel members will bring their perspectives on these and on how to help keep innovative combination products in Europe.
Speaker(s)
Flora Giorgio, MPharm
European Commission, Belgium
Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation
Lars Hyveled-Nielsen, MPharm
Zealand Pharma, Denmark
Regulatory Project Director
Bjorn Eriksson
Medical Products Agency, Sweden
Christelle Bouygues, PharmD
European Medicines Agency, Netherlands
Regulatory Affairs Senior Officer
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