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 use cases from our global SEND user community.
19 October 2022 8:45 am – 12:30pm EDT
Agenda
8:50am – 9:00am Opening - CDISC-SEND Leadership Team (LT) Introductions
9:00am - 9:25am Updates from the JPMA (Japan Pharmaceutical Manufacturers Association) SEND Team
9:25 – 10:25 am Industry and FDA Q&A Sessions
- 20 min, Share Public Responses to "Ask the Industry" from the Spring 2022 F2F Meeting – (CDISC-SEND LT)
- 30 min, "Ask the FDA" submitted via eData - (FDA)
- 10 min, FDA Discussion (if needed)
10:25 – 10:35 am Break
10:35 – 11:05am FDA CDER OBI eData Presentation
- FDA eData Team/TRC Presentation
11:05 – 11:35 am. Current Status and Next Steps for the SEND standard - SEND LT
11:35 – 12:30 pm. Industry Sponsor Presentations
- 25 min, SendigR
- 30 min, BioCelerate update on cross study analysis and predictive toxicology
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Meeting ID: 161 291 8052