The regulatory session was an initiative proposed by Anders Lindahl and Anna Nordmark from the Swedish Medical Products Agency with the aim to communicate on the scientific research within OrBito and to facilitate a face to face discussion with regulatory representatives from US, EMA and Japan on research activities within OrBito which are envisaged to have a future regulatory impact. In addition to the regulatory presenters on site, other members of the global regulatory stakeholder group joined the session by WEBEX.
As with previous OrBiTo annual meetings, day two was an open science day, supported by APGI, and was attended by a number of delegates who were not part of the OrBiTo consortium. In addition to sharing key updates from the on-going research within the OrBiTo work packages, the open science meeting brought together key representatives from regulatory agencies to discuss the implementation of biopharmaceutics tools in regulatory submissions.
The presentations and discussions will be summarised in a manuscript to be published in Molecular Pharmaceutics.