Quantitative Interpretation of Genetic Toxicity Dose Response Data for Risk Assessment and Regulatory Decision-making: Current Status, Persistent Challenges, and Emerging Priorities

 Co-chairs: Paul White, Health Canada, Ottawa, Canada; Andreas Zeller, Hoffmann-La Roche, Basel, Switzerland

Date: Thursday, December 3, 2020

Cost: Free to EMGS members; $75 for non-members (non-members can join EMGS for $75 USD)

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ABOUT THIS WORKSHOP

The workshop will (1) provide a brief overview of the state of the science regarding quantitative interpretation of genetic toxicity dose-response data, including a brief overview of the BMD combined covariate approach for potency ranking and MOA investigation, (2) a summary of recent genotoxicity risk assessment case studies, particularly those related the pharmaceutical impurities such as NDMA, (3) an in-depth overview of issues pertaining to developing consensus CES values for genotoxicity endpoints, (4) an in-depth overview of issues pertaining to the determination of effective AF values for routine interpretation of genotoxicity dose-response data for establishment of HBGVs, and (5) a brief overview of issues pertaining to interpretation of in vitro genotoxicity dose-response data in a risk context. The workshop will include two 1hr time slots for structured discussion aimed at delineating action items and next steps.