D5.8 - Policy White paper: Lowering barriers for regulatory pathway of In Silico Trial Tools

This white paper will examine these critical needs within the context of policy development and implementation. First, an overview will be given of the current state of the policy and legislative landscape, followed by a review of the current policies relevant for in silico trial technologies. We will then address the shortcomings in this state-of-the-art framework, including barriers such as the lack of a trained workforce, absence of a clear regulatory pathway, and other barriers hindering the advancement of in silico trials. Finally, drawing on efforts within the silico community to overcome these challenges, we will present the main recommendations for moving forward.