The main target of biomedical world when dealing with an infection disease is to understand its biological dynamics and to find a way to cure it. The strong involvement of the immune system modelling and a perspective on how to apply agent based models  to simulate biological scenarios will be discussed.  A computational framework of the EC funded STriTuVaD project will be presented as a working example.

Before a new medical product can be sold in a country, evidence must be provided to the regulatory agency of  that country supporting the claim that such new product, if  used as expected and under properly controlled conditions, is  safe (when it does not worsen the health of the recipient) and  effective (when the product does improve the recipient’s health).

After an initial resistance, the recommendations towards in silico trials by the United States Congress (2015) and the European Parliament (2016) towards their respective regulators, opened the concrete possibility for the biomedical industry to use computational methods for demonstrating the safety and efficacy of a new product. The lecture will introduce the regulatory issues and barriers that in silico trials are facing with.