CDISC invites you to an FDA-hosted public broadcast during the SEND Team’s spring 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.

01 April, 2020    9:00am – Noon EDT

Agenda

9:00am – 9:45am           OCS Visionary Presentation – Dr. Lilliam Rosario

9:45am – 10:30am         FDA Answers Common Questions Coming Through the eData Email Box – FDA Team, Stephanie Leuenroth-Quinn, Patty Brundage

10:30am – 10:45am       BREAK

10:45am – 11:15am       Industry Topic Presentation – BioCelerate SEND Harmonization Initiative:  A proposal to better harvest the value from SEND data – William Houser, BMS

11:15am – 12:00pm       OBI/eData Team Update: Technical Rejection Criteria, simplified TS.xpt usage – Heather Crandall, Ethan Chen

Connection instructions:

Join the meeting: https://fda1.webex.com/fda1/j.php?MTID=mb17f0a38826bd462aafb7218b6ac0892
Meeting number (access code): 900 522 449
Meeting password:  JdZvtpyA278

To join by phone:

+1-210-795-0506 US Toll

+1-877-465-7975 US Toll Free

Global Call-in numbers: https://fda1.webex.com/fda1/globalcallin.php?MTID=m99946ce943d9279f1552943ede112312
Toll-free Calling restrictions: https://e-meetings.verizonbusiness.com/global/pdf/Verizon_Audio_Conferencing_Global_Access_Information_August2017.pdf