Toward a Regulatory Pathway for Using In Silico Trials in CE Marking Position Paper
A team of researchers of the In Silico World project, including several key Avicenna Alliance members, led by Prof. Francesco Pappalardo (University of Catania), Avicenna Alliance’ Pharmaceutical Strategy TF Co-Chair, recently published a Position Paper in IEEE Journal of Biomedical and Health Informatics (J-BHI). In Silico Trials (IST) plays a growing role in the development of new medical devices. This position paper reviews the current system for IST and recommends that the EU regulatory system should innovate to avoid more innovative companies to focus on other large markets.
