The 31st e-seminar of CompBioMed, titled Assessing the Credibility of Computational Models: Application of the FDA-Endorsed ASME VV-40, will be held on 26 July 2023, at 14:00 CEST. CompBioMed is a European Commission H2020 funded Centre of Excellence focused on the use and development of computational methods for biomedical applications.
Computational models in the medical field are more and more stepping out the door of the laboratories they were developed in to find practical applications in clinical or regulatory practice, for instance. In fact, terms such as digital twin in healthcare or in silico trials sound now very familiar to the scientific community. Still, a lot is about trust, and before a model is adopted by a clinician, a manufacturer, a regulator, its credibility must be demonstrated. In 2018 ASME issued the V&V-40 technical standard, which provides a Context of Use and Risk-oriented framework to establish the credibility of computational models. Alessandra Aldieri and Cristina Curreli will give an overview of this framework highlighting its key steps and providing CompBioMed experience with its application.