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Nonclinical Topics – Calling For Feedback

The Conformance with the tumor.xpt Specification within the Nonclinical Topics Working Group has produced a White Paper ‘Conformance with the Technical Specifications Document for Submitting Nonclinical Datasets for Evaluation of Rodent Carcinogenicity Studies of Pharmaceuticals’ along with a set of Conformance Rules. This White Paper outlines the development of standardised conformance rules for tumor.xpt datasets to enable automated validation, improve data consistency, and reduce manual effort in regulatory submissions for carcinogenicity studies..

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 20 May 2026.

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The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative.

This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you.

You can find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.

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New Member Onboarding Form

If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. 

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