Gaining acceptance in next generation Physiologically Based Kinetic (PBK) modelling approaches for regulatory assessment: Case studies

Video collection

2022

PBPK

OECD, EFSA

The OECD is increasingly exploring the use of alternative (non-animal) methods to aid the chemical risk assessment process. In 2021, the OECD published a Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes that aims to increase the confidence in the use of PBK models parameterised with data derived from in vitro and in silico methods, and help address “unfamiliar” uncertainties associated with these methods. Shortly after, the OECD organised an introductory webinar on “Gaining acceptance in next generation PBK modelling approaches for regulatory assessments”. This first webinar covered the assessment framework for PBK models that was developed to evaluate the attributes and uncertainties of these models and included discussions on sensitivity analysis.

Join us for the second webinar to hear about the application of the assessment framework for PBK models. This webinar will present two case studies and illustrate how the templates of the guidance were used to report and evaluate PBK models. A discussion will also take place on challenges related to the regulatory evaluation of PBK models and clarifications on aims and scope of these models will be provided.

If you are from the community of PBK model developers, or the proponent of a model in a regulatory submission, or a regulator who needs to assess the applicability of the models in chemical evaluations, this webinar is for you!

Programme and speakers:

- 13.00-13.10 Welcome by Magda Sachana (OECD Environment Directorate)
- 13.10-13.20 Short introduction to the OECD PBK Guidance by Cecilia Tan (US EPA)
- 13.20-13.35 Reporting and evaluation of PBK models from Bette Meek (University of Ottawa)
- 13.35 -13:50 Developing a PBK model: EFSA case study by Jean Lou Dorne (EFSA)
- 13.50-14:05 Developing a PBK model: NTP case study by Xiaoqing Chang (Inotiv)
- 14.05-14.40 Review of the two case studies by Bette Meek (University of Ottawa), Cecilia Tan (US EPA), Jean Lou Dorne (EFSA) and Xiaoqing Chang (Inotiv)
- 14:40-15:00 Q&A session moderated by Alicia Paini (esqLABS GmbH).