Good Simulation Practice (GSP) Task Force
Mission: Drafting a Good Simulation Practice document widely recognized and accepted similar to the Good Clinical Practice
In today's rapidly evolving medical landscape, computational modeling and simulation, known as in silico techniques, are increasingly prominent. These techniques bring along efficiency, precision, and cost-effectiveness, but they demand universally recognized standards for consistency and credibility.
With a steadfast commitment to elevating the standards of in silico methods, the GSP Task Force is set to pioneer and shape the computational modelling frontier in Europe and beyond.
Goals
- Generate support to tackle the lack of regulatory framework for CM&S by outreach to key stakeholders that should have an interest in the development of GSP Guidelines: now contributors and 1 publication of CoU
- Engage with regulators (EMA, FDA) to endorse the development of GSP Guidance document
- Develop a GSP guidance document to provide to regulators
The GSP paper “Toward Good Simulation Practice - Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products”has just been published on 23 February 2024.
This publication involved the collaboration of 144 experts, part of Avicenna Alliance, VPH Institute, and the EU-funded project InSilicoWorld, and coming from academia, industry, and regulatory agencies (including 13 M&S experts from the FDA’ s ModSimWG).
