2nd European Summit on In Silico Pharmaceutical Summit

Panelists included Andrea Manfrin (MHRA), Gavin Quigley (BSI), Ine Skottheim Rusten (formerly EMA and CEO of SRLAB) and Professor Alex Frangi from the University of Manchester and head of the UK's CEiRSI initiative in the field of health.

All participants emphasized the importance of in silico evidence and their organizations' readiness to accept the results of computational modeling and simulation as part of the regulatory approval process. Of course, they reminded the audience that the credibility of this in silico evidence must be demonstrated, as with any other evidence. Panelists explained that in silico data was more common in the regulatory approval process for pharmaceuticals than for medical devices, but both concluded that there was a clear trend towards in silico evidence.

This roundtable concluded that it was essential to communicate and collaborate more closely in the future; regulators encouraged the public to engage with them early and often.

The audience was pleasantly surprised by the regulatory authorities' open-mindedness towards in silico evidence. The ball is in our court to embrace this evolution!