Webinar – 2024 IVDR Sprint Series: Companion Diagnostics (CDx) – Critical Areas and Implications for Successful Development and Launch in the EU

by | Jun 20, 2024 | Webinars

In this recorded webinar, Amit Kumar Jain and Veronique Treil from Veranex share some of our first-hand industry expertise, helping you stay attuned to the latest industry developments, challenges and advancements specifically related to Companion Diagnostics and IVDs. By watching this webinar, you will:
  • Learn how to establish and leverage strategic partnerships at both early and late stages of Companion Diagnostics development to ensure commercial launch readiness and market success;
  • Gain an understanding of the EU IVDR definition and types of CDx, specific requirements for conformity assessment, the distinction between clinical trial assays and CDx, and the critical timelines for performance study investigation;
  • Understand the importance of Health Technology Assessment (HTA), the role of clinical and non-clinical evidence in securing reimbursement, and strategies to achieve stakeholder adoption for successful market entry of CDx.


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