Webinar Series (part II): Regulatory Requirements, Technical Documentation, & Performance Evaluation for In-House Developed Tests

Date

Thursday, June 15th 2023 (16:00 - 17:00)

Price

€240.00 for non-members

€240.00 for members

Language

English

Organised by

The QbD Group

Categories

Tags

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.

Register now: https://us06web.zoom.us/webinar/register/WNftBFIlESDajIg8UXQDCfQ#/registration