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IVD and Companion Diagnostics in the Era of Personalised Medicines
Session Chair(s)
Anja Wiersma, PHD
CEO and senior consultant
Mi-Ce Consultancy, Netherlands
IVD and Companion Diagnostics in the Era of Personalised Medicines
Speaker(s)
Scoping and Definitions of Personalised Medicine, Difference in Interpretation between Device and Pharma World, and the Role of Diagnostics in Personalised Medicine
Stephen Lee
Medicines & Healthcare Products Regulatory Agency (MHRA), United Kingdom
Senior Regulatory Policy Manager
What is an IVD, How Are They Regulated, and IVDR Provisions on Companion Diagnostics
Sue Spencer
UL, United Kingdom
Head of Global Medical Devices
Successful Cooperation or Hurdles and Mutual Misunderstanding?
Luc van Hove, MD, PHD
QARAD, Belgium
Principal Consultant