CDISC Standards in the Regulatory Submission Process (What’s New and What’s Ahead) – Webinar Slides – Download

CDISC Standards in the Regulatory Submission Process - What’s New and What’s Ahead – The webinar was held on Thursday, 26^th January 2011.

We can find following agenda in the webinar slides

• SDTM Amendment 1 Wayne Kubick, CDISC

• CDER Common Data Standards IssuesDocument, Chuck Cooper, CDER

• CDER/CBER’s Top 7 Standards Issues Dhananjay Chhatre, CDER and Amy Malla, CBER

• SEND Update - CDER Timothy Kropp, CDER

• CDRH: CDISC Update, Terrie Reed, CDRH

• Q&A CDISC and FDA Panel

To download the webinar slides use the below mentioned weblink

http://www.cdisc.org/stuff/contentmgr/files/0/8d99d69f1195d2a2954e62d2fbb3470f/misc/cdisc_standards_in_fda_submissions_2012_01_26pdf.pdf