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Regulatory Submissions, Information, and Document Management Forum


Session 6 Track 4: eCTD AdPromo Panel Discussion

    Session Chair(s)
      Thomas J. Noto

      Thomas J. 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:

  • 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
Speaker(s)
    Thomas J. Noto

    Speaker

    Thomas J. Noto

    • Senior Director, Regulatory Operations
    • Lexicon Pharmaceuticals, United States
    Thomas  Christensen, RAC

    Speaker

    Thomas Christensen, RAC

    • Senior Regulatory Affairs Manager
    • SynteractHCR, United States
    Josephine  Secnik, MBA, MS

    Session 6 Track 4: eCTD AdPromo Panel Discussion

    Josephine Secnik, MBA, MS

    • Director – Ad/Promo Regulatory Affairs
    • Eli Lilly and Company, United States