In the last two years, a group of 144 experts from academia, industry, and regulatory agencies from all over the world condensed their expertise into a book entitled: “Toward good simulation practice: best practices for the use of computational modelling & simulation in the regulatory process of biomedical products”.
The scope of this document is to provide a list of the best practices on the use of computer simulation in assessing the safety and efficacy of medical products. The form we chose is a “Position Paper” - a public document providing an expert opinion to orient policies or standards. In this sense, the present document is not binding and represents only the consensus among some field experts. However, we hope this document might provide a starting point for a future standardisation effort by an appropriate body.
The final version will be soon published as an Open Access book by Nature Springer.
The very final revision round has just been closed. We take the opportunity to thank all the experts that contributed to this important initiative and we will inform you as soon as the book will be published!