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Why do we need a policy change?

The legislation in place today for regulating in silico products actually predates the existence of these technologies. In order for the in silco market to grow and for research in this field to be encouraged, a policy framework for in silico medicine needs to be developed. Just as the internet has created an urgent need to reform how we think about issues such as data security and IPR, in silico medicine requires we reevaluate our existing health policy structures.

Even the most advanced and predictive model has little value to industry if it cannot be submitted as evidence of the effectiveness or safety of their product:

  • Manufacturers of medical devices who use in silico technologies must be provided with a framework for submitting this data to notified bodies, health authorities and evaluators of health technologies.
  • Similarly for pharmaceuticals, a framework for admissibility of in silico clinical trial data needs to be developed so that we can move from exploratory clinical trials in humans, to a scenario where we seek to confirm what we know from in silico methods.

Incentives in policy need to be provided for industries that pioneer this research which has the potentially to drastically decrease overall research costs and greatly improve patient safety. Providing a system for assessing modelling and simulation data that supplement efficacy or safety data is required to bring healthcare into the digital era.

“If healthcare is to move into the digital era, we need new policies that will enable this transition”

NEWS

News Virtual launch of

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 (CM&S) in the Regulatory Process of Biomedical Products" took place, marking a significant milestone in regulatory science and industry.

News Appointment of Avicenna Formal Administrators

Appointment of Avicenna Formal Administrators

At its recent General Assembly, the members of the Avicenna Alliance have confirmed that three members of the Avicenna Board will act as legal representatives of the Avicenna Alliance. As a Belgian non-profit organisation, the Avicenna Alliance allocate the following positions:

News Avicenna at FDA / MDIC Event in Washington, April 16 - 17

Avicenna at FDA / MDIC Event in Washington, April 16 - 17

Many representatives of the Avicenna Alliance networked with good friends and in silico thought leaders from around the world at the FDA / MDIC symposium on Computation Modeling & Simulation in Washington.

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