SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

2019 Electronic Drug Registration and Listing Using CDER Direct Header Banner

Electronic Drug Registration and Listing
Using CDER Direct
October 22, 2019

Continuing Education Credit

  • This one-day conference has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
  • This event 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.
  • SOCRA 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.
  • Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.
Agenda & Speaker Bios

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Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 4, uploaded on October 9, 2019.

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Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

Files, Certificate & Recordings

ZIP of the Workshop Slides

Session Recordings:

  • Welcome from CDER’s Office of Compliance: Rosemary Cook
    View Recording
  • Keynote from the Drug Registration and Listing Staff: Paul Loebach
    View Recording
  • Establishment Registration and Labeler Code Requests: Don Duggan & Puii Huber
    View RecordingView Q&A Recording
  • NDC Reservation, Drug Listing, Compounded Product Reporting: Soo Jin Park, Troy Cu & David Mazyck
    View Recording
  • Listing Certification and Inactivation: Leyla Rahjou Esfandiary & Regie Samuel
    View Recording
  • Compliance Program and Case Study: Julian Chun & Tasneem Hussain
    View Recording
  • DRLS Town Hall: DRLS Staff
    View Recording
Questions & More Information

Questions?

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More Information

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