Preconference Workshop: From Concept to Compliance: Overcoming the Regulatory Challenges of Clinical Performance Studies

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, taking into account country specific nuances in the continued absence of EUDAMED.

This preconference workshop will review the current regulatory landscape of clinical performance studies 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 (IVDR 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, Ireland, Netherlands, Italy, and Spain).

The preconference workshop will include a case study 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 the 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.

The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!