Starting in late 2016 and early 2017, any company or organization collecting, exchanging and submitting nonclinical data to the US Food and Drug Administration (FDA) from studies within scope will be required to adhere to SEND guidelines and regulations.
Charles River has been involved with the CDISC SEND initiative since 2003. In 2007, a representative from Charles River joined the CDISC SEND team and was nominated as the SEND Findings Sub-Team Lead in 2008.
This webinar provides an overview of SEND 3.0, the requirements for SEND-compliant submissions, the benefits of SEND and the changes you may need to make in order to be SEND compliant.
- Audrey Walker, Associate Director of Electronic Submissions, Charles River