VPHi workshop

A triple helix format refers to the active participation of academia, regulators and industry. Regulatory science related to in silico technologies is receiving more and more attention. Testimony to this are the ASME V&V40 standard for medical devices and the collaborative work ongoing to establish guidelines for the use of in silico models (beyond the pharmacometrics models) in the drug development context.

In this workshop, the focus is on in silico models of drug-device combinations. Several speakers from academia and industry will present the work they are doing in this space. Regulators will subsequently present the regulatory perspective on the evaluation of drug-device combinations and the open questions related to the credibility establishment of the in silico models. At the end of the workshop, a discussion between the presenters and participants will address these questions and identify additional challenges.

Please register here!

This workshop is organised in the framework of european projects, including SimCardiotest.