Join the upcoming webinar from the American College of Toxicology (ACT) featuring Marc Ellison, Director, Regulatory Solutions, here at Instem
Regulatory submission and SEND compliance are critical in preclinical research – stay ahead with expert insights from Marc. He’ll be sharing key considerations and best practices to ensure efficient, compliant submissions.
Thank you to the American College of Toxicology for hosting this insightful event with Marc.
Live Webcast Details:
Wednesday, March 12
11:30 AM – 1:00 PM Eastern
We hope to see you there!
Full Webcast Description:
Since the FDA’s adoption of the Standard for Exchange of Nonclinical Data (SEND) in 2016, it has continuously evolved, expanding beyond general toxicology to include disciplines such as Development and Reproductive Toxicology and genetic toxicology. Initially driven by FDA requirements for nonclinical safety assessment submission for Investigational New Drug Applications and New Drug Applications, SEND datasets are currently being utilized for innovative purposes, such as creating virtual control groups.
This session will explore the development of the SEND standard and the data currently within its scope. It will focus on the ongoing expansion of the standard, highlighting new data and study types that will soon be incorporated. The current submission requirements will be outlined, and upcoming changes will be discussed, addressing the challenges of remaining compliant with an ever-evolving standard. The webinar will also describe how the industry maximizes the value of SEND investments by collaboratively utilizing the standard to unlock and reuse legacy study data.
There is no fee for joining the live webinar, but advance registration is required.
