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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 5: Medical Devices & Combination Products

Session Chair(s)

Tim  Chesworth

Tim Chesworth

  • Senior Director Regulatory Affairs
  • AstraZeneca, United Kingdom
Ben  Thompson

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)

Torsten  Kneuss

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
Amanda  Matthews

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, United Kingdom
Bjorg  Hunter, MSc

Industry and Notified Body in Getting to MDR Readiness

Bjorg Hunter, MSc

  • Department Manager, RA NextGen Drug Device
  • Novo Nordisk A/S - Soeborg - Soeborg, Denmark
Jonathan  Sutch, PhD

Industry and Notified Body in Getting to MDR Readiness

Jonathan Sutch, PhD

  • Medicinal Technical Specialist, BSI & Team group member
  • BSI Group, United Kingdom
Representative Invited

Contributing Panelist

Representative Invited

  • European Commission - DG SANTE