In this free webinar, learn about navigating the US Investigational Device Exemption (IDE) and EU In Vitro Diagnostic Medical Devices Regulation (IVDR) for bioanalytical assays used for clinical trial inclusion/exclusion. The featured speakers will discuss the pathways to compliance with the IDE and IVDR and how assays can be used for clinical trial enrollment. Attendees will gain insight from the speakers' knowledge and experience to help accelerate the path to meeting IDE and IVDR requirements for patient enrollment.
TORONTO, May 27, 2025 /PRNewswire-PRWeb/ -- The use of bioanalytical assays as a means of patient inclusion/exclusion criteria in clinical trials implicates these assays as in vitro diagnostic devices (IVDs) under the newest EU In Vitro Diagnostic Medical Devices Regulation (IVDR), while requiring compliance with Investigational Device Exemption (IDE) requirements in the US. In this webinar, the featured speakers share insights from their interactions with global regulatory agencies, consultants, and sponsors who are pursuing the path to IDE and IVDR in drug development and clinical trials.
Attendees will gain insight into the IDE requirements for assays used as inclusion/exclusion criteria in clinical trials. The speakers will share insights into the pathways to compliance with IVDR and how assays can be used for clinical trial enrollment. Attendees will gain practical knowledge from the speakers' experience to help accelerate the pathways to IDE and IVDR.
Register for this webinar to learn how to navigate IDE and IVDR requirements to streamline patient enrollment and clinical development programs.
Join experts from BioAgilytix, Marco Klinge, PhD, Associate Director of Bioanalytical Operations; Luke Armstrong, PhD, Associate Director/Bioanalytical Project Manager; Natalie Smith (panelist), PhD, HCLD(ABB), CLIA Laboratory Director; Amanda Hays (panelist), PhD, Scientific Officer; Rob Nelson (panelist), PhD, Scientific Officer; and Will Williams, MS, Senior Director of Lab Operations, for the live webinar on Wednesday, June 11, 2025, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Navigating IDE and IVDR Requirements in Drug Development.
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