Webinar Series (part I): Impact of the EU IVD Regulation on Clinical Drug Trials

Date

Thursday, June 8th 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 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.

Register now: https://us06web.zoom.us/webinar/register/WN_bb9ppVWBRVGiN5JUIkUicA#/registration