Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 September 12, 2024

Conference | Virtual

---

• Date: September 12, 2024
• Time: 8:45 a.m. - 4:45 p.m. ET

---

Topics & Presentations	Speakers
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 1
Keynote Address	Matthew Lash, JD Deputy Director Office of Compliance Center for Drug Evaluation and Research (CDER)
CDER Direct Establishment Registration Demo       Establishment Registration Highlights   Complying with Establishment Registration Requirements	Regie Samuel Technical Information Specialist Drug Registration and Listing Branch (DRLB) Division of Labeling, Registration, and Unapproved Drugs (DLRUD) Office of Unapproved Drugs & Labeling Compliance (OUDLC) CDER Jose Cabrera Technical Information Specialist DRLB | DLRUD | OUDLC | CDER Tasneem Hussain, PharmD Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER
CDER Direct Labeler Code Request Demo   Labeler Code Request Highlights   Complying with Labeler Code Request Requirements	Puii Huber Technical Information Specialist DRLB | DLRUD | OUDLC | CDER Laurie Simonds, GWCPM Technical Information Specialist DRLB | DLRUD | OUDLC | CDER Vikas Arora, PharmD Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER
Q&A Panel	Regie Samuel, Jose Cabrera, Tasneem Hussain, Puii Huber, Laurie Simonds, and Vikas Arora
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – Part 2
CDER Direct Drug Listing   Listing Updates and Blanket “No Changes” Certification Demo   Drug Listing Highlights     Complying with Drug Listing Requirements	Troy Cu Technical Information Specialist DRLB | DLRUD | OUDLC | CDER Yogesh Paruthi, PharmD Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER Vikas Arora, PharmD Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER and Tasneem Hussain
NDC Reservation   Future Format of the National Drug Code   NDC Assignment to Drugs	David Mazyck Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER Leyla Rahjou-Esfandiary, PharmD Branch Chief DRLB | DLRUD | OUDLC | CDER Soo Jin Park, PharmD, MS Lieutenant Commander | United States Public Health Service (USPHS) Regulatory Officer DRLB | DLRUD | OUDLC | CDER
OTC Drug Listing Updates and Validation   Drug Amount Reporting for Listed Drugs       Who Should Not Register or List	Leyla Rahjou-Esfandiary and Obinna Ugwu-Oju, MS Division Director Office of Pharmaceutical Quality (OPQ) Office of Quality Surveillance (OSI) CDER Yogesh Paruthi, PharmD Consumer Safety Officer DRLB | DLRUD | OUDLC | CDER
Case Studies	Julian Chun, PharmD, MBA Consumer Safety Officer DRLB | DLRUD | OUDLC | OC | CDER
Q&A Panel	Troy Cu, Yogesh Paruthi, Vikas Arora, Tasneem Hussain, David Mazyck, Leyla Rahjou-Esfandiary, Soo Jin Park, Obinna Ugwu-Oju, Yogesh Paruthi, and Julian Chun

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS CONFERENCE (Hosted by CDER SBIA)

This annual event will provide:

• A demonstration on how-to submit establishment registration and drug listing data using CDER Direct.
• An overview on registration and listing regulatory requirements and compliance framework.
• Case studies for an interactive learning experience at the end of the day.

INTENDED AUDIENCE

• Regulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.
• Consultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.
• Healthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.
• Foreign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.

TOPICS

• Explaining the proposed rule on the National Drug Code (NDC) format.
• Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.
• Discussing drug amount reporting requirements.

LEARNING OBJECTIVES

• Explain who must register and list.
• Provide an overview to FDA’s registration and listing compliance program.
• Describe the formats and segments of the National Drug Code (NDC).
• Discuss OTC drug listing requirements and its relation to OTC Monograph Drug User Fee Program (OMUFA) assessment.

FDA RESOURCES

• Federal Register Revising the National Drug Code Format and Drug Label Barcode Requirements
• Electronic Registration and Listing Instructions
• FDA Direct
• Strength Conversion in Drug Listing
• Structured Product Labeling Resources