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  4. Webinar: OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them- Oct. 25, 2019 - 10/25/2019
  1. News & Events for Human Drugs

Webcast

Event Title
Webinar: OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them- Oct. 25, 2019
October 25, 2019


Date:
October 25, 2019
Time:
1:00 PM ET
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Watch Recording Slides

1:00 p.m. - 2:00 p.m. Eastern | This webinar is FREE.

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 

CONTINUING EDUCTION

This course:

  • has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
  • is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
  • Continuing education certificates are available only for those who attend in-person or via webcast in real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.

FDA RESOURCE

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

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

TECHNICAL INFORMATION

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit: Adobe Connect Diagnostic Test

 


Event Materials

Title File Type/Size
Promotional Submissions in eCTD Format PDF pdf (238.18 KB)