SEND Virtual Meetings: Public Broadcast Hosted by FDA

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

One tap mobile:

US: +16692545252,,1617758043#,,,,*566851# or +16468287666,,1617758043#,,,,*566851#

Join by Telephone

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Dial: US: +1 669 254 5252 or +1 646 828 7666 or +1 669 216 1590 or +1 551 285 1373 or 833 568 8864 (Toll Free)

Meeting ID: 161 775 8043

Passcode: 566851

International numbers

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Meeting ID: 161 775 8043

Passcode: 566851

SIP: 1617758043@sip.zoomgov.com

Passcode: 566851