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Session 1 Track 2 - M1: Ad/Promo
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations, Lexicon Pharmaceuticals, United States
Explore the new specifications for submitting advertising and promotional materials, based on over 6 months of industry use. Topics will include an industry perspective on transitioning Ad Promo submissions from paper to eCTD, as well as best practices for implementing and using the latest Module 1. An overview of FDA interactions on this topic will also be highlighted.
Learning Objective : Share experiences gained through interaction with FDA specifically pertaining to Ad/Promo Submissions the new Module 1 specification. Discuss areas of ambiguity or unique situations encountered while planning and executing ad/promo submissions using the new M1 DTD v3.3.
Speaker(s)
Sandra Krogulski, MA
Director, GRSO Innovation and Business Operations Lead, Bristol Myers Squibb, United States
Advertising and Promotion Submissions Using US Module 1 v3.3: A Year in the Life - Questions Asked and Lessons Learned
Ian Oldham
Senior Manager, Regulatory Submissions Management, Teva Pharmaceuticals, United States
Buying Into Promotional and Advertising Submissions in eCTD
Robert Connelly, MBA
Senior Director, Global Regulatory Operations, Incyte, United States
What We've Learned About the FDA's New Module 1
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