Fit for Use Workstream Status
The CDISC SEND Team, in collaboration with the PhUSE Nonclinical Test Submission Forum Team, will be sharing the current status of the SEND usability pilot, the “Fit for Use” submission pilot.
October 26, 2016 4:00 – 5:00PM EDT
To join this web conference, please use connection information at the SEND Fit for Use public wiki: http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home
Open to the Public - Please note this conference call is limited to 100 attendees.
SEND-compliant Dataset Submission Process and Nonclinical Test Submissions Discussions with FDA EData Team
The CDISC SEND Team is holding a discussion with the FDA EData Team regarding SEND-compliant dataset submission process and nonclinical test submissions, in general. This will also include some discussion related to the recent CDER SBIA Webinar: “Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria”.
October 27, 2016 11:00 AM – 12:00 PM EDT
Open to the Public - Please note this conference call is limited to 100 attendees.
To join this web conference, please use connection information at the SEND Fit for Use public wiki: http://wiki.cdisc.org/display/NSFFUW/Nonclinical+%28SEND%29+Fit+for+Use+Workstream+Home