webinar
Lessons learned from a CDx study; A perspective from Regulatory and IVD
by James Lappin
Lessons Learned from a CDx Study Webinar
GenDx, a leader in molecular diagnostics, and ARC Regulatory are pleased to share with you the webinar, Lessons Learned from a CDx Study: A Perspective from Regulatory and IVD.
This insightful session focuses on the challenges and experiences involved in conducting a companion diagnostic (CDx) study under both the EU’s In Vitro Diagnostic Regulation (IVDR) and the U.S. Food and Drug Administration (FDA) frameworks.
The webinar will be presented by James Lappin, Associate Director of Global Regulatory Compliance - Translational Biomarkers at ARC, and Jules Petit, Project Manager for CDx at GenDx. Together, each will share their own recent experiences from the perspective of a regulatory consultant and that of an IVD manufacturer, referring to an ongoing HLA-CDx study being executed in both the EU and U.S
Topics Include:
- Their journey from CDx concept to regulatory submissions.
- How to navigate the regulatory challenges under IVDR and FDA regulations.
- Practical insights and lessons learned throughout the CDx study process.
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