CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s fall virtual meetings. The broadcast is an opportunity for stakeholders to stay informed on what’s going on with the development of SEND and its use in regulatory submissions, as well as hear from our global SEND user community.
18 October 2023 10:00 – 11:30 am EDT
Agenda
10:00 a.m. – 10:10 am Opening - CDISC-SEND Leadership Team (LT) Introductions
10:10 a.m. – 10:40 a.m. CDER Clarifications on Study Data Technical Conformance Guide
10:40 a.m. – 11:25 a.m. New SEND Releases
- 10:40 a.m. – 10:55 a.m. Cadence of development, Audrey Walker
- 10:55 a.m. – 11:05 a.m. Status of releases, Ben Sefing
- 11:05 a.m. – 11:15 a.m. Summary SENDIG-DART v1.2, Ronne B. Baracani
- 11:15 a.m. – 11:25 a.m. Summary SENDIG-GeneTox v1.0, Mike Wasko
11:25 a.m. – 11:30 a.m. Next Steps: Industry Survey
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