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Virtual launch of

Virtual launch of "Toward Good Simulation Practice" book



Virtual launch of "Toward Good Simulation Practice" book

On May 8, 2024, the virtual launch of "Toward Good Simulation Practice: Best Practices for the Use of Computational Modeling and Simulation in the Regulatory Process of Biomedical Products" took place, marking a significant milestone in regulatory science and industry.

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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