In silico methods, or using computer modelling and simulation (CM&S), is utilised to amplify and accelerate the design, development, testing and regulatory approval of new medical treatments. To achieve this goal, the healthcare community needs a clear and harmonised regulatory framework to ensure the necessary credibility of this approach for maximising patient safety while accelerating medical innovation.
In the last decade, policy makers from around the world have paid an increasing attention to this technology having the promise to accelerate medical innovation and make health care safer, more affordable, more effective and more efficient for their citizens. In addition, adopting this technology, widely used in other industries (such as aerospace, automotive or hightech among others), is also giving a clear competitive advantage to the industrial healthcare community operating in their region.
In leading regions, policy makers have facilitated research funding and built the legislative framework to validate computational models and encouraged their usage in faster regulatory approval process without compromising with safety and effectiveness for the benefits of local citizen and industries.
NEWS
Avicenna Alliance publishes the 5th Release of its In Silico Glossary
The Avicenna Alliance ispleased to announce the publication of the 5th Release of the Avicenna …
Computational Modeling and Simulation of Medical Devices - Book Release
The medical device industry is increasingly adopting computational modeling and simulation (CM&S) throughout the product life cycle—from early-stage design and prototyping to regulatory submissions and post-market performance evaluation. A key challenge across all these applications is establishing whether a model is sufficiently credible to support (regulatory) decision-making. The ASME V&V 40 standard, published in 2018, introduced a risk-based framework for assessing model credibility and has gained broad acceptance across the industry.
BSI Joins the Avicenna Alliance to Advance Trust in In Silico Medicine
The Avicenna Alliance is delighted to welcome the British Standards Institution (BSI) – …