4th September 2018, European Parliament (Brussels)



MEP Lieve Wierinck, in collaboration with the Avicenna Alliance, organised this conference to strive towards a common international framework for the validation and acceptance of computer modelling and simulation (CM&S) and adding the topic on the agenda of regulators and policy makers. The event brought together experts speakers from the EU, the USA, and India, from the FDA, leading medical device, pharmaceutical and software companies, and elite academic researchers. They discussed why a regulatory framework is crucial, what are the benefits for patients, the various industry stakeholders and regulators in and outside of the European Union.

According to the participants, the legislation in place today for regulating healthcare products predates the existence of CM&S technologies also known as in silico medicine; it is no longer fit for purpose. To address the dilemma of reducing time and cost to bring new medical treatments to market without compromising patients safety and to deliver the promise of personalised medicine, we must embrace new digital solutions. The impact of modelling and simulation in providing regulatory evidence was illustrated by a variety of examples including tailored treatments that increase efficacy and safety as well as drastically reducing costs of clinical trials. One example demonstrated that adopting an in silico approach helped to release a product 2 years earlier than expected by reducing the clinical trials by 256 patients and the estimated cost by $10 Million while allowing to treat 10,000 patients.

FDA will continue to raise awareness about in silico medicine, to engage with national and international stakeholders to pursue harmonisation efforts, and to advance regulatory decision-making by establishing Good Simulation Practices. Ms. Wierinck committed to ensuring that in silico medicine will receive funding as part of Horizon Europe.This White Paper highlights the potential of computer modelling and simulation in medtech and the regulatory and political barriers to unlocking that full potential.


To download the white paper please click here.

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