Webinar Overview
Your nonclinical research journey is almost at its conclusion, and now your data has the story to tell. What happens if it can’t be heard?
The Standard for Exchange of Nonclinical Data (SEND) guidelines were updated in March 2023, and it is critical that you are aware of the most current submission requirements for both CDER and CBER divisions within the FDA. In particular, Non-GLP Toxicology and DART studies must now follow these guidelines.
View this webinar to get the vital knowledge you need about the important SEND updates and how they impact your submissions, including:
- Current FDA CDER and CBER SEND data requirements
- Upcoming CDISC standards and SEND Implementation Guides
- CDISC Open Rules Engine (CORE)
- CDISC Library
Webinar Presenters
Audrey Walker
Sr. Director and SEND Practice Lead, CDISC SEND Industry Mentoring Team Lead
Charles River