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.
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