A workshop on the use of innovative modelling and simulation approaches during the development and regulatory assessment of medicines will take place at the European Medicines Agency (EMA) on 21 November 2016.
You can follow a live broadcast of the workshop by clicking on the ‘multimedia’ tab on the event page.
The workshop is organised as part of a public consultation on a new EMA guidelineon physiologically-based pharmacokinetic (PBPK) modelling and simulation that was launched in July 2016. Comments on the guidance are invited until 31 January 2017.
The aim of the workshop is to bring together regulatory agencies, pharmaceutical industry, academia, patient representatives and software developers to discuss the role of PBPK models in the development and regulatory review of medicines. The workshop also aims to explain the main elements of the new guidance, gather the views of stakeholders and provide details on qualification procedures and evaluation of such models.
PBPK modelling is increasingly used by medicine developers, e.g. to predict the interaction between medicines in the body or to help define the initial dose of a medicine in pediatric and first-in-human trials.
As new scientific data are generated and confidence in PBPK modelling increases, these models are expected to be used in other aspects of the development of medicines in the near future.
EMA’s draft guideline clarifies how these models can support decision making in the context of a marketing authorisation application. It provides detailed advice on the data that should be included in a PBPK modelling report of an application dossier. The document also emphasises the need for PBPK platforms to be ‘qualified’ and evaluated for a specific use if they are to support regulatory decisions.