[IEEE-bhpjobs] March 20 NCRAF: Great Regulatory Submission Practices for an eCTD World

[esther L]

March 20, 2008 meeting
  Hosted by NCRAF

"GRSP" – Great Regulatory Submission Practices for an eCTD World!

Speakers + Panel Discussion: Nancy Chew, Susan Sisk, Drai Boyd and Roxie 
Loudenslager

Objectives – at the end of this session you will:

     * Recognize some of the components of INDs and NDAs/BLAs that sound 
simple but may become rate-limiting to submission if you don’t plan ahead
     * Understand how good document planning and an awareness of 
document management/granularity impacts the writing process for 
eCTD-format submissions
     * Know how writers and regulatory strategists can help publishers, 
regulatory operations professionals and statisticians complete the 
submission on time
     * Know how regulatory operations professionals can help writers and 
regulatory strategists deliver the right messages to FDA reviewers.



Click http://www.ncraf.org/images/ncraf/events/event_2008_03.pdf
for an event flyer. Please post!

Networking reception 5:30-6:30; Panel discussion 6:30-8:00 pm


Date & Time: 	Thursday, 20 March 2008, 05:30 PM — 08:00 PM
Location: 	Elion-Hitchings Building (GSK Campus)
3030 E. Cornwallis Road Map
Durham, NC
27709-3398
-- 
-- Esther L.,  esther-L at mailsnare.net or esther-L at alumni.virginia.edu
Speaking only for myself.