Companion Diagnostics (CDx) – Navigating the Regulatory Challenges

Companion Diagnostics (CDx) – Navigating the Regulatory Challenges is organized by Fleming and will be held from Dec 03 - 04, 2025 in Vienna, Wien, Austria.

Course description
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe. These processes are proving challenging and, in the absence of detailed guidance, often result in roadblocks and delays to development of CDx.

EU Competent Authority, Notified Body and Regulatory Consultant CDx experts will share their experience at this seminar, to demystify the EU regulation of CDx and how it differs from US legislation. They will provide guidance on the alignment of medicinal product and CDx development, applicability of the IVDR and how to ensure smooth performance study and conformity assessment applications. There will be opportunities to discuss and learn from real examples at interactive workshops, as well as to hear inside knowledge on activities ongoing within the European Union to streamline these processes.

Topics:

• The output from the workshop will be invaluable to ensure the success of your predictive biomarker-guided medicinal product development.
• Predictive biomarker-restricted medicines
• Regulation of companion diagnostic devices (CDx) in the US and EU
• Alignment of medicinal product and CDx development
• EU authorisation processes for CDx performance studies and CE marking
• Interactive workshops with opportunity to submit examples and questions to a competent authority, notified body and regulatory consultant experts