Join us at ESTP 2026 – Visit Instem at Booth 10!
Heading to ESTP in Kraków? Come and meet the Instem team at Booth 10 and discover how our industry-leading solutions are helping organizations streamline preclinical research, strengthen regulatory compliance, advance predictive toxicology, and unlock greater value from their data.
Sponsored Session – “The Missing Domain: What SEND Does for In Vivo Pathology and No One Has Built for NAMs”
The session will cover:
- How SEND domains were developed for in vivo pathology and what that standardisation has enabled for regulatory review and data reuse
- Why NAMs data currently lacks an equivalent framework, and the practical consequences of that gap for sponsors trying to include NAM evidence in regulatory submissions
- What a NAMs-specific SEND domain might need to capture, and the scientific and regulatory challenges involved in defining it
- The implications for regulatory acceptance of NAM-generated evidence, particularly in the context of the FDA Modernization Act and evolving EMA guidance
- A call to action, whether directed at CDISC, regulators, or the wider industry, to begin closing this gap
Presented by Szczepan Baran, CSO | Tuesday, 29 September | 16:15–16:30pm | Room S3
Discover Provantis®
Our comprehensive preclinical study management solution designed to streamline end-to-end workflows and help teams work more efficiently. And don’t miss our new Non-GLP Pathology module! Stop by Booth 10 to see what’s new and speak with our experts.
Want to discuss your specific needs in more detail? Contact us to schedule a 1:1 meeting with our team during the event.
For full event details, visit the ESTP Event Website.
