The Avicenna Alliance attends the EMA workshop in Amsterdam

This workshop was a particularly informative meeting bringing together members of regulatory authorities — the EMA, of course, but also the MHRA and the FDA, as well as several national regulatory agencies—academic leaders such as Francesco Pappalardo and representatives of the Virtual Physiological Institute, as well as representatives of the pharmaceutical industry and software developers.

Numerous presentations described the methods used to develop, verify and validate models following well-established methods for defining “Questions of Interest”, “Context of Use”, “Risk Assessment”, etc. Although PBPK, PKPD and other methods were discussed at length, other solutions involving various mechanistic models, including 3D models, were also addressed, illustrating the rapid progress made in Europe in terms of the acceptance of In Silico Evidence (ISE) for the regulatory approval process.

We still have a long way to go. But we are delighted that important milestones have been reached, among others thanks to the contribution of the Avicenna Alliance and its partners, who are determined to accelerate medical innovation for the patients.