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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 4: eCTD AdPromo Panel Discussion

Session Chair(s)

Thomas  Noto

Thomas Noto

Senior Director, Regulatory Operations

Lexicon Pharmaceuticals, United States

The FDA AdPromo eCTD Guidance was finalized in June 2019 and becomes mandatory in June 2021. Although the guidance has been out for more than four years, many 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 season 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:

  • Understand the process of submitting AdPromo materials in eCTD
  • Anticipate the challenges to changing from a legacy process
  • Gain perspective into all AdPromo stakeholders in and their perspectives on what’s important


Thomas  Noto


Thomas Noto

Lexicon Pharmaceuticals, United States

Senior Director, Regulatory Operations

Heather  Fisher, MS


Heather Fisher, MS

Arivis, United States

Director, Regulatory Operations

Rob  Labriola, MS


Rob Labriola, MS

Garuda Therapeutics, United States

Exec. Director, Regulatory Operations

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