August 19 -20, 2024 – Washington, DC
Please join us as Beaufort’s SVP, Global Regulatory and Quality, Karin Hughes, Ph.D. will be presenting at the 16th Annual Next Generation Dx Summit. Her presentation, “Clinical Trials with CDx—Navigating the Complexity of the IVDR“, will be at 10am on Tuesday, August 20th.
Presentation Summary:
The implementation of Regulation (EU) 2017/746 (IVDR) has heightened the complexity of clinical trials using companion diagnostics (CDx). With Eudamed lacking a functional Clinical Investigations and Performance Studies module, sponsors must navigate individual national procedures, submitting applications, modification notifications, and final reports to each Member State where CDx studies are conducted. This presentation addresses these challenges and offers insights into solutions derived from supporting pharmaceutical and diagnostic manufacturers engaged in combined studies across the EU.
Appointments are being scheduled now to discuss this topic and other emerging trends that can impact your product development.
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About the conference:
Cambridge Healthtech Institute is proud to present the 16th Annual Next Generation Dx Summit which will take place at the Capital Hilton in Washington, D.C., on August 19-21, 2024. The Next Generation Dx Summit is the nexus for international thought leaders to discuss diagnostic advancement and technology innovation. This year’s event provides a valuable window on the state-of-the-art forecasting and future trends in point-of-care and decentralized testing, infectious disease, liquid biopsy, multi-cancer early detection, reimbursement, regulation, and companion diagnostics to improve the standard of care in medicine. This must-attend Summit offers incomparable networking and complete coverage of the most timely and important topics for the industry.
View conference website: https://www.nextgenerationdx.com/