In Silico Trials, the use of computational modelling & simulation in the development and regulatory assessments of biomedical products is an emerging practice in the biomedical industry. While the first technical standards, such as the ASME VV-40:2018, are appearing, there is yet no reliable source for best practices in this field.
We are pleased to announce the upcoming publication of “Toward Good Simulation Practice: Best Practices for the Use of Computational Modelling & Simulation in the Regulatory Process of Biomedical Products”. This Open Access book is the result of a collaboration between 144 experts from academia, industry, and regulatory agencies worldwide, including In Silico Trials CEO, Luca Emili.
As a co-chair- together with Marco Viceconti – of the Good Simulation Practice (GSP) Task Force within Avicenna Alliance, as well as member of the committee for the adoption of In Silico Medicine of the Italian Ministry of Health, Emili has been an advocate for the use of in silico technology in the biomedical industry.
The book aims to provide a reliable source for best practices and establish technical standards for the use of computational modeling and simulation in the development and regulatory assessments of biomedical products.
The pre-final draft is now available for public revision. We invite you to download the draft booklet HERE. and submit your comments by email to: firstname.lastname@example.org by May 22nd, 2023. Your feedback will be considered by the chapter editors as they finalize the book for publication by Nature Springer.
Join us in our efforts to advance the use of in silico technology in the biomedical industry and establish best practices for the use of computational modeling and simulation in regulatory assessments. We look forward to your contributions to this important initiative.
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