6 Apr 2022 - 6 Apr 2022
OECD Webinar on "Gaining acceptance in next generation PBK modelling approaches for regulatory assessments: Case studies"
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.
The second webinar will focus on the application of the assessment framework for PBK models. It 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: (Time CET)
13.00-13.10 Welcoming - Magda Sachana (OECD)
13.10-13.20 Short introduction to the OECD PBK Guidance - Cecilia Tan (US EPA)
13.20-13.35 Reporting and evaluation of PBK models - Bette Meek (University of Ottawa)
13.35 -13:50 Developing a PBK model: EFSA case study - Jean Lou Dorne (EFSA)
13.50-14:05 Developing a PBK model: NTP case study - Xiaoqing Chang (Inotiv)
14.05-14.40 Review of the two case studies - Bette Meek (University of Ottawa), Cecilia Tan (US EPA), Jean Lou Dorne (EFSA), Xiaoqing Chang (Inotiv)
14.40-15.00 Q&A - Moderated by Alicia Paini (esqLABS GmbH)
Organizer
OECD
Location
Zoom webinar