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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 1 Track 2 - M1: Ad/Promo

Session Chair(s)

Thomas  Noto

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.


Sandra  Krogulski, MA

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

Ian  Oldham

Buying Into Promotional and Advertising Submissions in eCTD

Ian Oldham

Teva Pharmaceuticals, United States

Senior Manager, Regulatory Submissions Management

Robert  Connelly, MBA

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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