Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products(Synthesis Lectures on Biomedical Engineering)

This open access book, the Community of Practice led by the VPH Institute, the Avicenna Alliance, and the In Silico World consortium has brought together 138 experts in In Silico Trials working in academia, the medical industry, regulatory bodies, hospitals, and consulting firms. Through a consensus process, these experts produced the first attempt to define some Good Simulation Practices on how to develop, evaluate, and use In Silico Trials.  Good Simulation Practice constitutes an indispensable guide for anyone who is planning to engage at any title with In Silico Trials.

Table of Contents:
Introduction.- Theoretical foundations of Good Simulation Practice.- Model development.- Model credibility.- Possible regulatory pathways.- Possible Health Technology Assessment pathways.- Ethical review of in silico methodologies.- The sponsor.- The investigator: modellers and analysts.

About the Author :
Marco Viceconti is one of the key figures in the in silico medicine international community: he edited the first European research roadmap that in 2006 introduced the concept of the Virtual Physiological Human. After that, he founded the VPH Institute, an international non-profit organisation that coordinates this research community, and drove the creation of the Avicenna Alliance, which represents the biomedical industry interests in this domain. He founded and led for seven years the prestigious Insigneo Institute for in silico Medicine, the first large-scale European research institute entirely devoted to in silico medicine. He is a fellow of the UK Royal Academy of Engineering, one of the 25 members of the World Council of Biomechanics, and in 2021 won the Huiskes Medal for Biomechanics. According to SCOPUS he published 368 papers (H-index = 52).  Luca Emili is an entrepreneur and investor, founder and current CEO of InSilicoTrials Technologies, the first global platform that makes easy-to-use modelling and simulation to accelerate the pace of innovation in the healthcare and life science industry. From 2001 to 2010 he was CEO of Emaze, a cybersecurity company that became one of the market leaders in Italy by automating security analysis for complex networks and devices. He is a member of the Cloud Security Consultative Group in EMA and is responsible for the Research Collaboration Agreement between InSilicoTrials and the FDA. He is also a member of the Board of Avicenna Alliance and of the committee for the adoption of In Silico Medicine of the Italian Ministry of Health. He is a journalist, an entrepreneur in the internet services business, and a start-up investor.  He holds a degree in Economy and Business from the University of Trieste, Italy, where he still lives today when he’s not travelling across the USA and Europe.