SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance

Drug Master File Workshop 2022 Banner

Drug Master File (DMF) Workshop:
GDUFA III Enhancements and Structured Data Submissions
November 30, 2022

Agenda & Speaker Bios

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Event Agenda

The agenda is still being refined and may be updated over time. The current version is v4, uploaded on November 29, 2022.

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Speaker Biographies

The speaker biographies document provides detailed information about the Workshop speakers.

Files, Certificate, & Recordings

Download Presentation Slides:

Evaluation & Certificate:

Evaluation & Certificate of Attendance

Session Recordings:

YouTube Livestream Recording

Questions & More Information

Continuing Education:

    Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event (until December 14, 2022).

    This workshop has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation 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.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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More Information

If you have questions regarding the content of the event or other CDER-specific information, please: