CDISC invites you to attend a public broadcast of SEND topics during the CDISC SEND Team's fall 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.

Wednesday, October 03, 2018

Agenda (all times shown are Eastern Daylight Time)

1:00 – 2:00 (60 min) FDA Presentation by Dr. Lilliam Rosario, Director of the FDA/CDER Office of Computational Science (OCS)

2:00 – 2:30 (30 min)  FDA/OND Reviewer Panel 

2:30 – 3:00 (30 min)  "FDA Reviewers ask the Sponsors" Panel 

3:00 - 3:15 Break

3:15 - 3:50 (35 min) Study Data Technical Conformance Guide Discussion – Led by  Dr. Helena Sviglin, Regulatory Information Specialist FDA/CDER Office of Computational Science (OCS)

3:50 - 4:20 (30 min) SEND Data Support from OBI Perspective Presentation by Dr. Ethan Chen, Program Manager of eData Team, Office of Bioinformatics (OBI)

4:20 - 4:40 (20 min) Industry Consortium Updates: Biocelerate and eTransafe

4:40 - 5:10 (30 min) JPMA Update, Gen Sato, SEND Taskforce (TF) Team, Non-clinical Evaluation Expert Committee, Japan Pharmaceuticals Manufacturers Association; Eisai Co., Ltd.,

Connection instructions:

CDISC-SEND Fall 2018 F2F Industry/Sponsor Meeting 
Wednesday, October 3, 2018 
12:30 pm  |  Eastern Daylight Time (New York, GMT-04:00)  |  5 hrs

Join the meeting: https://fda1.webex.com/fda1/j.php?MTID=ma84c920bfe954772f8b61d3fed2ffea7
Meeting number (access code): 900 414 085 
Meeting password: Tce82pcM

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?serviceType=MC&ED=7928042&tollFree=1
Toll-free Calling restrictions: https://e-meetings.verizonbusiness.com/global/pdf/Verizon_Audio_Conferencing_Global_Access_Information_August2017.pdf

IMPORTANT NOTICE: Please note that this Webex service allows audio and other information sent during the session to be recorded, which may be discoverable in a legal matter. By joining this session, you automatically consent to such recordings. If you do not consent to being recorded, discuss your concerns with the host or do not join the session.