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

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


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More Information

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