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IVDs

CDx or Not CDx, That is The Question – The Impact of The IVD Regulation on IVDs Used in Pharmaceutical Clinical Trials

Tuesday, May 7, 2024
15:05 – 16:05 CEST
Location: B 07 + B 08
Learning Level: Advanced
Description: The recent implementation of the EU IVD regulations (Regulation (EU) 2017/746 IVDR) and clinical trial regulations (Regulation (EU) 536/2014 CTR) has introduced several challenges for bringing companion diagnostics to market in Europe. The lack of guidance and clear solutions is leading to delays in the development of precision medicines and their companion diagnostics and putting strain on relationships between IVD and drug stakeholders.

This session will include a panel of speakers that represent a laboratory with in-house tests, an IVD manufacturer, a drug manufacturer, and a regulatory authority. The speakers will discuss and debate how they are navigating the challenges faced today from their unique perspectives. Topics will include interventional tests used during medicinal trials, tests used for study participant stratification, bridging studies, and CDx CE marking under the IVDR.

The session will begin with brief introductions from each speaker who will highlight the biggest challenges from their unique perspective. This will be followed by a moderated debate on specific topics and time for questions from the participants.

Participants will be able to identify solutions to challenges relevant to the products and scenarios with which they work. This knowledge and awareness will help them build strategies to enable more efficient development and clinical studies for future products.

Learning Objectives:

  • Upon completion of this session, participants should be able to: • Understand the current regulatory environment for companion diagnostics in Europe
  • Upon completion of this session, participants should be able to: • Identify strategies for use of tests within different phases of medicinal trials under the IVDR and CTR
  • Upon completion of this session, participants should be able to: • Identify solutions for working collaboratively between drug and IVD stakeholders to enable efficient co-development