CDISC invites you to attend a public broadcast of SEND topics during the CDISC SEND Team's spring face-to-face meeting at the FDA CDER facility. The broadcast is an opportunity for stakeholders to stay informed on what's going on with the development of SEND as well as ask any questions you may have to FDA reviewers. FDA reviewers will also have the opportunity to ask questions to Sponsors.
PUBLIC BROADCAST, April 25, 2018 1:00 - 4:30PM EDT
1:00 – 2:00 FDA Presentation by Dr. Lilliam Rosario, Director of the FDA/CDER Office of Computational Science (OCS)
2:00 – 2:45 FDA Reviewer Panel – Audience will be given opportunity to ask questions live. Remote attendees can submit questions via the chat function of the webinar during the broadcast.
2:45 – 3:00 <<Break>>
3:00 – 3:30 "FDA Reviewers ask the Sponsors" Panel – Sponsors are invited to respond to questions from the FDA reviewers
3:30 – 4:30 Guidance Discussion (Study Data Technical Conformance Guide, Data Standards Catalog) – Led by Dr. Helena Sviglin, Regulatory Information Specialist FDA/CDER Office of Computational Science (OCS)
To register, please visit: https://attendee.gotowebinar.com/register/7511575759060222465