From 15 to 17 April 2024, the city of Hyattsville, MD, will host the FDA/MDIC Symposium on Computational Modeling and Simulation – Generating Regulatory In Silico Evidence. Consortium members from Charité – Medical University of Berlin and the VPH Institute, among others, will attend the event.
The Symposium is co-organised by medical device industry leaders and FDA members. The event aims to drive innovation and foster collaboration in computational modeling and simulation to advance regulatory evidence in the medical device industry
The agenda will include a pre-symposium workshop with various regulatory training sessions (Monday, April 15) and the main symposium (Tuesday-Wednesday 16-17 April), as below.
Monday 15 April – CM&S Pre-symposium Workshop – Training sessions:
1. ASME V&V 40-2018 standard “Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices”
2. FDA Guidance on “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”
3. FDA Guidance on “Reporting of Computational Modeling Studies in Medical Device Submissions”.
Tuesday-Wednesday 16-17 April 2024 – Main symposium
The main symposium, through panel discussions, will present best practices and strategies to ensure models meet the highest standards of credibility and reliability.
It will explore the cutting edge of applying computational evidence in both clinical and non-clinical settings to generate evidence for regulatory decision-making, with the aim of uncovering the potential of computational modelling and simulation in shaping the future of regulatory assessments and decision protocols.