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Session 11: Track B: eCTD Use and Ad Promo Materials
Session Chair(s)
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)
Providing Regulatory Submissions in Electronic and Non-Electronic Format
Jason Cober, MPA
OPDP | OMP | CDER | FDA, United States
Lead Project Manager
Promotional Labeling and Advertising Materials for Human Prescription Drugs
Josephine Secnik, MBA, MS
Eli Lilly and Company, United States
Director – Ad/Promo Regulatory Affairs