Need help navigating the ever-changing landscape of laboratory testing for clinical trials under the new IVD regulation? Gain a clearer understanding of the IVDR with our two-part webinar series, covering the following topics:
How assays in clinical trials are impacted by the IVDR;
The impact of IVDR on CDx;
Understand the documentation requirements for customized laboratory assays;
Get familiar with the performance evaluation requirements for customized laboratory assays.
Our Device Compliance Senior Expert Pieter Bogaert will give you more information about:
regulatory aspects for assays used in clinical trials
understanding IVDR Article 5.5 for in-house developed tests
understanding IVDR Annex I General Safety & Performance Requirements
performance Evaluation of in-house developed tests
Pieter Bogaert has a PhD in Biotechnology from Ghent University and has extensive experience in managing global laboratory CROs. At Qarad (part of the QbD Group), he serves as a senior consultant and has a proven track record of advising IVD manufacturers on submitting IVDR-compliant technical documentation to Notified Bodies. He is also proficient in facilitating the implementation of IVDR regulatory requirements within EU health institutions.