Webinar series by QbD - 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 this 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.