FDA Webinar: OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them

  • October 25, 2019
  • 1:00 PM – 2:00 PM (Eastern, UTC – 0400)
  • Virtually Online

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 the reviewer as quickly as possible. Topics for the webinar include:

  • The most common types of errors seen in promotional submissions in eCTD format,
  • How submitters can identify those errors prior to submitting, and
  • 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.

Continuing Education Credits:

  • This one-hour webinar has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
  • This webinar 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.
  • This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration
  • This webinar has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
  • Attendance certificates are only available during the two weeks after the event. Live event attendance is required.

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