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Accelerating CMC Workshop
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
- Quality Product Steward/Head of Project Office Medical Devices
- Bayer AG, Germany
Upcoming Challenges with Device Regulations and Ongoing Advocacy with Key Regulators
Amanda Matthews
- Senior Director, GCMC for Combination Products & Medical Devices
- Pfizer R&D UK, Ltd, United Kingdom
Industry and Notified Body in Getting to MDR Readiness
Bjorg Hunter, MSc
- Director
- Novo Nordisk, Denmark
Industry and Notified Body in Getting to MDR Readiness
Jonathan Sutch, PhD
- Medicinal Technical Specialist, BSI & Team group member
- BSI Group, United Kingdom
Contributing Panelist
Representative Invited
- European Commission - DG SANTE
