Workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation

Date: 21/11/2016
Location: European Medicines Agency, London, UK
The workshop provides an opportunity to discuss comments received on the draft guideline on PBPK modelling and simulation during public consultation (this consultation is open until 31 January 2017), explain its key messages and provide more details on qualification procedures and evaluation of drug models. It will also aim to communicate EMA's current thinking on the utility of PBPK to stakeholders from other regulatory agencies, the pharmaceutical industry, academia, patient representatives and software developers.



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