Virtual launch of Toward Good Simulation Practice book

This comprehensive position paper, developed by an international consortium of more than 135 experts, is aimed at leveraging CM&S for regulatory decision-making and supporting the development, optimization, and safety evaluation of medical products.

Event Highlights:

Introduction by Book Editors:

Luca Emili from InSilicoTrials and Marco Viceconti from the University of Bologna introduced the book, highlighting its importance for the future of regulatory science.

Impact of Good Simulation Practice (GSP):

Pras Pathmanathan from the FDA discussed the expected impact of GSP on regulatory processes and industry practices.

Book Presentation:

Liesbet Geris (VPH Insitute & KU Leuven) explained the theoretical foundations.
Cristina Curreli (University of Bologna) discussed model development and credibility.
Cécile F. Rousseau (VCLS) covered qualification pathways and ethical review processes.

Roundtable and Q&A Session:

Moderated by Thierry Marchal from Ansys, it featured book contributors and international stakeholders, while also engaging the audience.

The book introduces GSP as a new standard akin to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), tailored to ensure the safe and effective use of CM&S in the regulatory evaluation of biomedical products. GSP encompasses the use of "In Silico Methodologies"—a term used to denote CM&S as tools in regulatory processes, particularly for medical devices and pharmaceuticals. This initiative represents a crucial step towards integrating advanced computational methods into regulatory frameworks, potentially transforming the development and approval processes for medical products.

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