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In Vitro Diagnostics

Give Me Data: Challenges and Opportunities of Real-World Evidence

Tuesday, October 27, 2020

11:15 – 12:15 CET

Session Leader(s)

Michael Maier, MBA, RAC

Senior Partner
Medidee Services SA
Lausanne, Vaud, Switzerland

Slides

Speaker(s)

Tim Farley, PhD

Senior Consultant
Medidee Services SA
Lausanne, Vaud, Switzerland

Slides
Sandra Klompmaker, PhD

Senior Associate
Medidee Services

Slides

In the context of the requirements set in the IVDR for clinical data, this session gives an overview and discusses methods and approaches that have been used to collect real world evidence for the benefit of patients and healthcare in general.

PROGRAM

1 –

Introduction: The closed loop between risk management, performance studies, clinical evidence, post-market surveillance and post-market performance follow-up – Give me Data! – Sandra Klompmaker / Medidee – 15 mins
2 - Challenges and Opportunities of Real-World Evidence – field evaluation of IVD - Tim Farley / Medidee – 40 mins
3 – Q&A – Panel all 2 speakers