The document is open for revision until the 22nd of May.
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 published as an Open Access book by Nature Springer. As we want this document to represent the consensus among the entire Community of Practice as much as possible, we are now making the pre-final draft available for public revision.
You can download the draft booklet HERE.
If you have any comments or requests for change, these should be submitted by email to:
Deadline: Monday, May 22nd, 2023.