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Session 5: Medical Devices & Combination Products
Session Chair(s)
Tim Chesworth
Senior Director Regulatory Affairs
AstraZeneca, United Kingdom
Ben Thompson
Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom
In this session, we discuss the status of the MDR implementation in Europe and will get an overview of the upcoming global challenges in device registration and drug device combination products. The main objective of the session is to share industry experience of the evolving device regulations with a view to enabling more efficient device registration.
Speaker(s)
Quality systems - How does industry develop a quality system that covers pharma and devices effectively
Torsten Kneuss
Bayer AG, Germany
Quality Product Steward/Head of Project Office Medical Devices
Upcoming Challenges with Device Regulations and Ongoing Advocacy with Key Regulators
Amanda Matthews
Pfizer R&D UK, Ltd, United Kingdom
Senior Director, GCMC for Combination Products & Medical Devices
Industry and Notified Body in Getting to MDR Readiness
Bjorg Hunter, MSc
Novo Nordisk, Denmark
Director
Industry and Notified Body in Getting to MDR Readiness
Jonathan Sutch, PhD
BSI Group, United Kingdom
Principal Medicinal Technical Specialist
Contributing Panelist
Representative Invited
European Commission - DG SANTE
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