NAM Use for Regulatory Application

SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497.

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Wednesday, October 1, 2025
10am-12pm ET / 14:00-16:00 UTC

PRESENTERS

Emily N. Reinke, Ph.D., D.A.B.T; Principal Investigator, Inotiv
Georgia Reynolds, MSc; Safety Science Leader, Unilever

ALSO FEATURING

Joe Reynolds, PhD; Mathematical Modeler, Unilever
Eryn Slankster-Schmierer, PhD; PCRM moderator

Skin sensitisation experts Emily Reinke, PhD, and Georgia Reynolds, MSc, will join NURA to present a training on SARA-ICE: Points of Departure for Skin Sensitisation Risk Assessment with OECD GL 497.

After providing a brief background on the basics of skin sensitisation, the speakers will describe the concepts of Adverse Outcome Pathways (AOPs) and how they are used in Defined Approaches. This will lay the groundwork for understanding OECD Test Guideline 497: Defined Approaches on Skin Sensitisation. They will review the Defined Approaches included in the guideline, how the guideline is structured, and what the new updates published in June 2025 entail. Finally, the experts will discuss the new in silico method known as SARA-ICE: Skin Sensitization Risk Assessment - Integrated Chemical Environment Model; they will give a live demo along with an overview of how SARA-ICE was designed, the difference between models, and how it could be applied in a case study.

Learning Objectives:

• Understand the basic concepts of skin sensitisation and how it is assessed using a Defined Approach
• Learn about the Adverse Outcome Pathway and how it is used for skin sensitisation assessment
• Understand the contents of OECD Test Guideline 497 and the June 2025 updates
• Learn how and when to use SARA-ICE

Resource Links:

• OECD Guidance Document 497

• NIH-NTP SARA-ICE Model

Register

NURA is developing several new in-person and virtual training opportunities, including:

• SARA-ICE Training
• A Hands-on QSAR Training
• Validation of NAMs

Join our mailing list to get updates on our latest learning opportunities. You can also use the form to provide feedback and suggest training topics. Alternatively, you can email us with your comments and suggestions at nura [at] pcrm.org. 

We would like to feature your human-based nonanimal approach in a webinar. 

You will have the opportunity to present your method to a diverse professional audience from industry, government, NGOs, and academia, followed by an audience-led Q&A session. We are looking for:

• Case studies of NAMs that have been submitted in investigational new drug (IND) applications.
• NAMs currently being used in regulatory applications or those that have the potential to replace animal use in regulatory applications.

Please submit your presentation title and abstract or speaker suggestion to nura [at] pcrm.org. 

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