WEBINAR SERIES
Impact of the EU IVD Regulation on Clinical Drug Trials
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.
Part 1: Impact of IVDR on clinical drug trials within the EU
- June 8, 2023
- 16:00 CEST
- € 240
Description
Our Regulatory Affairs Expert Anne Paulussen will tell you more about:
- the new European IVD (In Vitro Diagnostic) regulation
- how the new regulation applies to assays used in clinical (drug) trials
- the current state of play for companion diagnostics in the EU
- some of the challenges we are currently facing in this field
Speaker
Anne Paulussen
Anne Paulussen is a Regulatory Affairs professional with a strong background in Pharmaceutical Laboratory Techniques, highly experienced in drug-device combinations, biologics, and IVDs. At Qarad (part of the QbD Group), Anne provides expert advice and training to IVD customers on IVDR regulatory requirements. She also serves as a Subject Matter Expert for all clinical trial-related queries and companion diagnostics.
Webinar hosted by Qarad
the IVD experts in the QbD Group
Part 2: Regulatory Requirements, Technical Documentation, & Performance Evaluation for In-House Developed Tests
- June 15, 2023
- 16:00 CEST
- € 240
Description
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
Speaker
Pieter Bogaert
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.
Webinar hosted by Qarad
the IVD experts in the QbD Group