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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 11: Track B: eCTD Use and Ad Promo Materials

Session Chair(s)

Jason  Cober

Jason Cober

  • Lead Project Manager, OPDP, CDER
  • FDA, United States
This session will provide an overview of the binding requirements and non-binding recommendations provided in FDA’s Final Guidance titled “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The presentation will discuss the Promotional submission types that will be required in eCTD format beginning in June 2021. Additionally, the presenters will discuss common questions and topics raised by Industry related to promotional eCTD Submissions and provide the FDA’s perspective along with real world solutions.
Learning Objective :

At the conclusion of this session, the participant should be able to:

  • Identify key dates and submission requirements associated with the publication of OPDP’s eCTD Ad Promo Final Guidance
  • Identify and adopt best practices for submitting promotional materials in eCTD format
  • Evaluate and compare existing eCTD processes to other successful eCTD implementation strategies

Speaker(s)

Jason  Cober

Providing Regulatory Submissions in Electronic and Non-Electronic Format

Jason Cober

  • Lead Project Manager, OPDP, CDER
  • FDA, United States
Josephine  Secnik, MBA, MS

Promotional Labeling and Advertising Materials for Human Prescription Drugs

Josephine Secnik, MBA, MS

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

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