EU-Japan bilateral meeting on the regulation for in silico trials


In Silico World recently hosted an EU-Japan bilateral meeting on standards, regulatory pathways, and regulatory science for in silico trials.

Our coordinator Prof. Marco Viceconti presented the European agenda around in silico medicine, in particular, the current situation regarding regulatory pathways for predictive models as a medical device and as medical product development tools in Europe and USA. A situation that – as our Japanese colleagues confirmed – does not differ so much from the one they are facing in their own country.

InSilicoWorld-EU-JAPAN meeting

 

The practice of In Silico Trials is still far from being established. Most of the research so far has been conducted in academic laboratories and thus far from the needs of industrial users. This is why our community works to consolidate a set of industrial practices that make easier and reliable the development and use of In Silico Trials solutions. After a brief summary of the Good Simulation Practice initiative provided by our experts, the Japanese delegation has been invited to Join our Community on Slack in order to provide their significant contribution to this initiative.

This was also an amazing chance to present and discuss the ASME VV-40:2018 technical standard and the various international activities conducted by the Avicenna Alliance. One of the main goals now is to work together to pursue shared objectives by promoting VPH Institute for academics and organisations and Avicenna Alliance for industrial organisations in Japan.

Thanks to Masanori Kikuchi, Kiyoyuki Chinzei, Keiko Koyanagi, Kohei Murase, InSilicoTrials, Ansys, DIN Deutsches Institut für Normung e. V., Marco Viceconti, Vincenzo Carbone, PhD, Cristina Curreli, Marc Horner, Ph.D., Thierry Marchal, Liesbet Geris, Heike Moser, Francesco Pappalardo