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Virtual Event

May 18, 2020 10:00 AM - May 20, 2020 3:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Advertising and Promotion Regulatory Affairs Conference

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

Session Chair(s)

Jason  Cober, MPA

Jason Cober, MPA

Lead Project Manager

OPDP | OMP | 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, MPA

Providing Regulatory Submissions in Electronic and Non-Electronic Format

Jason Cober, MPA

OPDP | OMP | CDER | FDA, United States

Lead Project Manager

Josephine  Secnik, MBA, MS

Promotional Labeling and Advertising Materials for Human Prescription Drugs

Josephine Secnik, MBA, MS

Eli Lilly and Company, United States

Director – Ad/Promo Regulatory Affairs

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