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, optimisation, and safety evaluation of medical products.
Event Highlights:
Introduction by Book Editors:

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

Impact of Good Simulation Practice (GSP):

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

Book Presentation:

• Liesbet Geris (VPH Institute & 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, Ansys & Avicenna Alliance, 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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