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This webinar is FREE. This webinar was recorded on Oct. 25, 2019.

ABOUT

This presentation provides an overview on:

1. the most common types of errors seen in promotional submissions in eCTD format,
2. how submitters can identify those errors prior to submitting, and
3. services provided by the Office of Prescription Drug Promotion (OPDP) to assist submitters who have questions related to the structure and data requirements associated with promotional submissions in eCTD format.

Now that FDA accepts promotional submissions in eCTD format, the agency’s goal is to reduce the time required to process submissions and route files from to the reviewer as quickly as possible.  While a promotional submission may pass validation at the electronic submissions gateway (ESG), it is possible for coding errors in the accompanying files to result in manual processing of the submission. Any failures during the automated processing can lead to delays in the delivery of promotional materials to the OPDP reviewer.

TOPICS COVERED

• Most common errors
  • Global errors
  • Submission type specific errors
  • Content and presentation errors
• Quality control and how to spot errors prior to submitting
• OPDP eCTD services and test submission process

LEARNING OBJECTIVES

• Identify the common errors that will result in failure of the automated processing of Promotional Submissions in eCTD format
• Evaluate quality control strategies and incorporate best practices into existing eCTD publishing processes
• Compare and assess the various services provided by OPDP’s eCTD team to support eCTD Submitters

INTENDED AUDIENCE

• eCTD submitters
• Ad/Promo regulatory operations managers
• Ad/Promo publishers
• Ad/Promo consultants

FDA SPEAKER

Jason Cober
Lead Project Manager
Office of Prescription Drug Promotion (OPDP) | CDER | FDA 

FDA RESOURCE

Final Guidance - Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs

 

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