Pre-Conference Workshop: Building Global CDx Studies: Strategic Planning Tools for IVD and Pharma Partners

Click here to download the agenda

Description: This pre-conference workshop will provide a comprehensive overview of the critical aspects involved in planning, executing, and reporting Clinical Performance Studies (CPS) under the changing regulatory framework. Attendees will gain practical insights into the complexities of conducting CPS in the EU, considering country-specific nuances and recent changes in the continued absence of EUDAMED. Presenters will also examine FDA requirements, drawing out key distinctions and alignment points with the EU approach, to help attendees navigate transatlantic regulatory expectations.

This preconference workshop will review the current regulatory landscape of CPS in the EU, highlighting the challenges faced from both the pharma and IVD perspectives. Presenters will give a brief overview of the IVDR requirements for CPS (Chapter VI, Annex XIII and XIV) with a focus on studies subject to Art. 58 requiring competent authority and ethical committee approval. However, the focus of the workshop will be on navigating the challenges and presenting strategies for coordination of CPS applications in countries with differing competent authority approval processes (i.e., Belgium, France, Germany, Austria, Netherlands, Spain, Denmark, Poland).

The preconference workshop will include multiple case studies where participants will use the knowledge and strategies discussed to put together a plan for a hypothetical product CPS application covering: CPS planning and strategy (including information to communicate in agreements with pharma partners), completion of submission packages, managing changes after approvals, and meeting reporting requirements (including safety). 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. This workshop will equip attendees with the knowledge and skills needed to effectively manage the complexities of CPS in the EU, ensuring compliance and facilitating the successful completion of clinical studies.