Navigating the Complexity of the IVDR
With the enactment of Regulation (EU) 2017/746 (IVDR), the landscape for developing companion diagnostics (CDx) has undergone significant transformation. With Eudamed lacking a functional Clinical Investigations and Performance Studies module, sponsors must consider individual national procedures, submitting applications, modification notifications, and final reports to each Member State where CDx studies are conducted.
This regulatory evolution demands that pharmaceutical and diagnostic partners devise new strategies and refine their processes, particularly when conducting a “combined study” that pairs a clinical trial of a medicinal product with a performance study of an in vitro companion diagnostics.
Karin A. Hughes, Ph.D., Beaufort’s SVP Global Regulatory and Quality addressed these pressing issues at the 16th Next Generation Dx Summit. Her presentation, “Clinical Trials with CDx—Navigating the Complexity of the IVDR” provided insights and effective strategies to help sponsors effectively develop a companion diagnostic in the EU.
Dr. Hughes is an industry leader in global regulatory affairs and Beaufort was proud to sponsor this important event to help support the effective development of companion diagnostic products.
Learn more about our comprehensive Companion Diagnostic and IVDR services and solutions or Contact Us today.