We are delighted to announce that our book “Toward Good Simulation Practice” is now FREELY available on line! This book marks a significant milestone in the field of in silico medicine, advocating for the strategic use of Computer Modelling and Similation (CM&S) as a regulatory decision support tool in the development of medical product.
In an exciting development for the field of in silico medicine, the publication of "Toward Good Simulation Practice - Best practices for the use of computational modelling & simulation in the regulatory process of biomedical products" is now officially available via Springer Nature in open access. This essential guide, edited by Prof. Marco Viceconti - chair of industrial bioengineering at the Alma Mater Studiorum – University of Bologna and InSilicoTrials' CEO Luca Emili, is a cornerstone for establishing standardized practices in Computational Modeling and Simulation (CM&S) within the biomedical regulatory process.
CM&S in healthcare aims to empower companies to leverage innovative technologies, potentially enabling them to reduce the cost and time of specific R&D activities by up to 90%, seamlessly integrating this perspective into the broader narrative of advancing regulatory science and healthcare innovation.
The book is a product of an extensive collaboration guided by the In Silico World consortium, with key contributions from the VPH Institute, the Avicenna Alliance and experts from the FDA, advocating for the strategic use CM&S as a regulatory decision support tool in developing drugs and medical devices. It aims to forge a clear, harmonized terminology, starting from "In Silico Trials" to "In Silico Methodology" for expanding regulatory discussions.
The content underscores the necessity for guidelines similar to the GxP standards, yet specifically tailored for in silico methodologies. It leverages the VV40 – 2018 standard as a model, proposing a consensus-driven framework to support modeling and simulation with good practices applicable across the spectrum of medical products.
A highlight of this publication is the collaboration with the FDA, underscored by contributions from a team of 13 FDA Modeling & Simulation experts, who provided chapter-by-chapter feedback and the insightful foreword by Pras Pathmanathan (the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health at the FDA). This partnership highlights a proactive engagement between regulatory bodies and the scientific community to foster advancements in medical product development.
This publication is a milestone in the in silico field, contributing to the maturation of CM&S for medical products. It's a step forward in stimulating further conversations among stakeholders and ultimately contributing to the development of community-accepted practices.
Download the book and discover more about Good Simulation Practice.
