PBPK for Regulators Workshop Summary - NAMS Roadmap (2023)

The UK FSA and the COT held a “PBPK for Regulators” workshop (December 2020) in a multidisciplinary setting with delegates from regulatory agencies, government bodies, academia and industry. The workshop provided a platform to enable expert discussions and presentations on the application of PBPK to human health risk assessment in a regulatory context as well as potential future research.

Main overarching conclusions of the PBPK workshop:

a)         PBPK modelling tools are applicable in the explored areas of use, and there is some expertise available for their utilisation.

b)         PBPK modelling offers opportunities from which to address questions for compounds that are otherwise not solvable.

c)         Widespread acceptance amongst regulatory bodies appears to be limited by lack of available in-house expertise.

d)         Familiarisation using real world case studies would help in developing more experts in the field and increasing acceptance.

e)         In a regulatory context, establishing fitness for purpose for the use of PBPK models require multi-partite discussion and harmonised guidance.

f)          Finally, PBPK modelling is part of the wider “new approach methodologies” for risk assessment.

Paving the way for a UK Roadmap-Development, Validation and Acceptance of New Approach Methodologies Workshop summary

The UK FSA and the COT held a workshop that took place online over 2 days in October 2021. It had participation from industry, academics and regulators. The aim of the workshop was to receive insights, comments and input from a wide variety of stakeholders and industry, academia and government, on the roadmap so that it can be developed and a useful and engaging document produced, that is beneficial to more than just the FSA and COT. This included a range of scientists, policy and lawyers, and working in the international space and engaging with the public. Furthermore, there were discussions on what is holding the progress back including a range of areas such as law, economics, socio-technical barriers and regulatory frameworks.