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 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
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.