Webcast | Virtual

Event Title

Regulatory Education for Industry: Drug Registration and Listing Workshop

October 8, 2020

Date:: October 8, 2020
Time:: 9:00 a.m. - 5:00 p.m. 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)