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.
03 November, 2021 8:30 am – 12:30pm EDT
Agenda
8:30am – 9:00am Introductions – CDISC SEND Leadership Team
9:00am – 9:30am Overview of CJUG (CDISC Japan User Group) SEND Activities – CJUG Send Team Leader
9:30am – 10:00am Scope of SEND Language Discussion Presentation - FDA OND* Team
10:00am – 10:30am Scope of SEND Language Discussion Q&A – CDISC SEND Leadership Team
- Industry response and feedback
- Industry should come prepared to discuss the following:
- What they think about the Scope of SEND Language?
- How this meet their needs?
- What has not been addressed?
*Please Note: (OND will not provide responses during F2F)
10:30am – 10:45am Ask the FDA – Industry Questions sent to eData – FDA OND/OBI Team
10:45am – 10:55am Break
10:55am – 11:40am eData/TRC Presentation – FDA eData Team
11:40am – 12:30pm What is planned for SENDIG v3.2/4.0?, The SEND 5 year plan – CDISC SEND Leadership Team
Connection Instructions:
Meeting URL: https://fda.zoomgov.com/j/1617758043?pwd=VWdiMk5XTjQ4cm1ISFlJb0UxUkowUT09
Meeting ID: 161 775 8043
Passcode: 0C#CcL
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Meeting ID: 161 775 8043
Passcode: 566851
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Meeting ID: 161 775 8043
Passcode: 566851
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