"Toward Good Simulation Practice - Best Practices for the Use of Computational Modelling and Simulation in the Regulatory Process of Biomedical Products"
The book emphasizes the need for a comprehensive set of guidelines akin to existing GSP standards but specifically tailored for in silico methodologies. Drawing on the example of the VV-40:2018 standard, the authors argue for a broader, consensus-driven framework that would encapsulate good modelling and simulation practices applicable across the entire spectrum of medical products.
At the heart of this initiative is the collaborative effort among leading organizations in the field: the VPH Institute, the Avicenna Alliance, and the EU-funded In Silico World project, representing a broad spectrum of practitioners: from academic researchers to industry professionals. The paper not only reflects the cumulative expertise and consensus within the In Silico World Community of Practice (ISW_CoP), but also sets the stage for the future development of standards that could significantly impact the safety, efficacy, and regulatory compliance of medical products.
Worth highlighting is the collaboration with the FDA: "As part of an active collaboration between ModSimWG and the Avicenna Alliance, a team of 13 FDA M&S experts covering all three medical product Centers (CDRH, CDER, and CBER) provided feedback on each chapter of this book. These FDA scientists supplement the dozens of subject matter experts across academia and industry who have reviewed the material throughout its development."
The aspiration is that this book will spark more dialogue among all parties involved and will eventually lead to the creation of widely recognized Good Simulation Practice, advancing the use of modeling and simulation in medical products.
Link to the publication
