Organ-on-chip – outlook on the regulatory pathway

Identify regulatory pathways for different applications and processes of organ-on-chip technology based on existing and novel routes. Identify gaps and shortcomings of existing regulatory processes, together with regulators (e.g. EMA, FDA, national authorities), e.g. in a round table format. Consider regulation at the European level but also include regulation outside Europe and practise in neighbouring/related sectors and applications. Define joint exemplary cases for organ-on-chip -based product innovation trajectories with best practises and suggest actions for regulatory improvements.