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Session 4: Preparing for the implementation of the EU Medical Devices Regulation
Session Chair(s)
Helen L Fitton
Vice President Regional Regulatory Affairs (Pharma)
GlaxoSmithKline, United Kingdom
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
This session will focus on the actions required to implement the EU Medical Devices Regulation new rules, which impact industry and agency, and the complexities which must be navigated to be ready for May 2020. More specifically, this session will address the documentation expected for Drug Device Combinations in the Quality part of the dossier, as introduced in the draft guideline which has been released for public consultation through to August 31st 2019. This part of the programme will share agency, industry and Notified Body perspectives.
Speaker(s)
Introducing the Guideline and the Authorities Perspective on its Implementation
Abigail Moran
MHRA, United Kingdom
Senior Pharmaceutical Assessor
The Industry perspective
Bjorg Hunter, MSc
Novo Nordisk, Denmark
Director
The Notified Bodies perspective
Jonathan Sutch, PhD
BSI Group, United Kingdom
Principal Medicinal Technical Specialist
The Notified Bodies perspective
Stephanie Göbel
TÜV SÜD Product Service GmbH, Germany
Quality Manager MHS
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