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Session 6 Track 4: eCTD AdPromo Panel Discussion
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
Although the eCTD AdPromo Guidance from the FDA has been out for more than two years, the majority of companies haven’t switched this process to eCTD. Commonly heard excuses are that it is complicated, expensive, and just too hard to change a process that entails hundreds of submissions a year per marketed product. This session will be an informative and fun panel discussion with seasoned experts who have made the switch to submitting AdPromo materials in eCTD format within their own companies, and lived to tell about it.
Learning Objective :
At the conclusion of this session, participants should be able to:
Speaker(s)
Speaker
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations
Speaker
Thomas Christensen, RAC
SynteractHCR, United States
Senior Regulatory Affairs Manager
Session 6 Track 4: eCTD AdPromo Panel Discussion
Josephine Secnik, MBA, MS
Eli Lilly and Company, United States
Executive Director – Product Communications Regulatory Affairs
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