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Advertising and Promotion Regulatory Affairs Conference

Session 12 Track B: FDA’s Guidance on Electronic Submissions of Promotional Materials

    Session Chair(s)
      Session Chair  Invited

      Session Chair Invited

      • United States
    Join members of FDA’s Office of Prescription Drug Promotion (OPDP) and an industry representative as they provide in-depth insight and advice regarding the submission of promotional materials in electronic Common Technical Document (eCTD) format to OPDP. FDA will provide a brief overview of the Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs draft guidance, review selected portions of the guidance in detail, and provide helpful technical tips for successfully submitting promotional materials to FDA as described in the guidance. An example of how one firm transitioned to eCTD will be shared. The presentation will wrap-up with a brief Q&A session.
      Josephine  Secnik, MBA, MS


      Josephine Secnik, MBA, MS

      • Director – Ad/Promo Regulatory Affairs
      • Eli Lilly and Company, United States
      Kemi  Asante, PharmD, MPH, RAC


      Kemi Asante, PharmD, MPH, RAC

      • Health Science Policy Analyst
      • FDA Office of Prescription Drug Promotion, United States

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Call for Posters Extended: January 16

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Complimantary Webinar

Navigating the Still Murky Waters of Manufacturer Communications: Promotion, Commercial Speech, and Scientific Exchange
Jan. 17 | 11:00AM-12:00PM ET

Preconference Short Course Options

Ad Promo Primer