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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)
Advertising and Promotion Submissions Using US Module 1 v3.3: A Year in the Life - Questions Asked and Lessons Learned
Sandra Krogulski, MA
Bristol-Myers Squibb Company, United States
Director, GRSO Innovation and Business Operations Lead
Buying Into Promotional and Advertising Submissions in eCTD
Ian Oldham
Teva Pharmaceuticals, United States
Senior Manager, Regulatory Submissions Management
What We've Learned About the FDA's New Module 1
Robert Connelly, MBA
Incyte, United States
Senior Director, Global Regulatory Operations
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