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  4. Regulatory Education for Industry: Drug Registration and Listing Workshop - 10/08/2020
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Webcast | Virtual

Event Title
Regulatory Education for Industry: Drug Registration and Listing Workshop
October 8, 2020


Date:
October 8, 2020
Time:
9:00 AM - 5:00 PM ET

 

Labeler Code Request
Topics include:

  • How to submit a Labeler Request SPL using CDER Direct
  • How to update an existing Labeler Code Request SPL
  • Why a labeler code is inactivated by FDA?
  • Top Dos and Don’ts
  • Q&A session with speakers

Don Duggan
Team Lead, Helpdesk Operations Team
Puii Huber
Technical Information Specialist
DRLS | OPRO | CDER

Establishment Registration
Topics include:

  • How to submit a registration SPL using CDER Direct
  • Establishment registration renewal
  • Establishment De-registration
  • US Agents and Importer requirements for foreign establishments
  • How to use DECRS
  • Top Dos and Don’ts
  • Q&A session with speakers

Regie Samuel
Technical Information Specialist
Leyla Rahjou Esfandiary
Lead Consumer Safety Officer
Vikas Arora
Pharmacist
Tasneem Hussain
Pharmacist
DRLS | OPRO | CDER

Drug Listing
Topics include:

  • How to reserve an NDC prior to drug listing
  • How to submit a Drug Listing SPL using CDER Direct
  • How to update an existing Drug Listing SPL, including discounting a drug
  • How to certify drug listing
  • How to use the NDC Directory
  • Top Dos and Don’ts
  • Q&A session with speakers

David Mazyck
Consumer Safety Officer
Troy Cu
Technical Information Specialist
Puii Huber
Technical Information Specialist
Tasneem Hussain
Pharmacist
DRLS | OPRO | CDER

503B Compounder Product Reporting using CDER Direct
Topics include:

  • How to submit a Product Reporting SPL using CDER Direct
  • Top Dos and Don’ts
  • Q&A Session with Speakers

Soo Jin Park
LCDR, USPHS
Regulatory Officer
DRLS | OPRO | CDER

 

Establishment Registration and Drug Listing Compliance Program
Topics include:

  • Compliance case process and manual overrides
  • Case Study of a violation
  • FDA’s Drug Listing Inactivation Project
  • Top Dos and Don’ts
  • Q&A session with speakers

Julian Chun
Pharmacist
Leyla Rahjou Esfandiary
Lead Consumer Safety Officer
DRLS | OPRO | CDER

Agenda

Download Slides


ABOUT

Join registration and listing staff in this workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. Ask questions to FDA subject matter experts.

INTENDED AUDIENCE

  • Regulatory affairs professionals working on registration and listing submissions
  • U.S. Agents
  • Importers
  • Manufacturers, repackagers, relabelers, and private label distributers
  • Submission vendors

TOPICS COVERED

  • Labeler Code Requests
  • Establishment Registration
  • Drug Listing
  • 503B Compounder Product Reporting using CDER Direct
  • Establishment Registration and Drug Listing Compliance Program 
  • All sessions include a Q&A panel

FDA RESOURCES

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:

  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • has been 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.
  • 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.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Event Materials

Title File Type/Size
eDRLS-2020-Agenda.pdf pdf (219.04 KB)
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