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

PDF Download
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.

PDF Download
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?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

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