During this webinar GenDx and ARC Regulatory will take you along in their recent experiences with a companion diagnostic (CDx), clinical performance study that is being executed in EU and US, under both IVDR and FDA. A CDx is a medical device that is used to provide information for the safe and effective use of a corresponding drug or biological product, for instance to determine the eligibility of a specific patient for a certain precision medicine intervention.
During the webinar James Lappin, Associate Director Global Regulatory Compliance at ARC Regulatory, will present the perspective from a Regulatory consultant (ARC Regulatory) and Jules Petit, Project manager CDx at GenDx will present the perspective from an IVD manufacturer (GenDx). The presenters will take you along on a journey from CDx idea to submissions to the different authorities and all the challenges the different regulatory landscapes present.
