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IVD Regulation and the Upcoming Changes in Regulatory Landscape

Track:
A New Era for Medical Devices and Diagnostics. How Is The Impact?

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0701

Type:
Session

Title:
IVD Regulation and the Upcoming Changes in Regulatory Landscape

Chair(s):
Christine Mayer-Nicolai, PharmD
Head Europe, Global Regulatory & Scientific Policy
Merck KgaA, Germany

Description:
IVD Regulation and the Upcoming Changes in Regulatory Landscape

Presentation(s) & Speaker(s):
This session discusses future challenges, opportunities and areas for collaboration within the new IVD regulatory landscape for PM- and CDx developers and relevant stakeholders such as Notified Bodies and EMA/National Competent Authorities.
Anna Hallersten, MSc
Head Regulatory Policy Europe
Roche Diagnostics, Switzerland

IVD Regulation and the Upcoming Changes in Regulatory Landscape
Sue Spencer
Head of Global Medical Devices
UL, United Kingdom