Conference

Event Title

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023

September 28, 2023

Date:: September 28, 2023
Time:: 8:45 AM - 4:45 PM ET

Topics & Presentations	Speakers
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 1
Keynote	Jill Furman, JD Director Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) \| FDA
How to Submit an Establishment Registration	Regie Samuel Technical Information Specialist Drug Registration and Listing Branch (DRLB) Division of Labeling, Registration and Unapproved Drugs (DLRUD) Office of Unapproved Drugs and Labeling Compliance (OUDLC) OC \| CDER \| FDA
Using the Appropriate Business Operation(s) and Business Qualifier(s)	Jose Cabrera Information Technology Specialist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Establishment Registration Renewal, Updates, and De-Registration	Regie Samuel
U.S. Agents and Official Contacts	Jose Cabrera
CDER Direct Labeler Code Request Demo	Soo Jin Park LCDR, USPHS Regulatory Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Who Will Be Assigned a Labeler Code and Who Won’t	Laurie Simonds, GWCPM Technical Information Specialist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Labeler Code Inactivation and Reactivation	Lalnunpuii Huber Technical Information Specialist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Updates, Mergers, and Acquisitions	Laurie Simonds
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 2
CDER Direct Drug Listing	Troy Cu Technical Information Specialist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Listing a Combination Product	Troy Cu
Strength Conversion in Drug Listing	Leyla Rahjou-Esfandiary Lead Consumer Safety Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Listing Updates and Delisting	Yogesh Paruthi Consumer Safety Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Blanket No Change Certification	Vikas Arora Pharmacist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
503B Registration and Product Reporting Using CDER Direct	Huascar Batista Senior Advisor Office of Compounding Quality and Compliance (OCQO) Office of Compliance (OC) \| CDER \| FDA
Q&A Discussion Panel	Troy Cu, Leyla Rahjou-Esfandiary, Yogesh Paruthi, Vikas Arora, Huascar Batista, Regie Samuel, Soo Jin Park, Laurie Simonds, and Lalnunpuii Huber
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 3
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration	Yajun (Jason) Tu, PharmD, PhD, BCSCP LCDR, USPHS Program Management Officer Policy and Operations Branch (POB) Division of User Fee Management (DUFM) Office of Management (OM) \| CDER \| FDA
National Drug Code (NDC) Reservation	David Mazyck Consumer Safety Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Format of the National Drug Code	Julian Chun Pharmacist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
NDC Assignment to Drugs	Soo Jin ParkLCDR, USPHS Regulatory Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Untitled Letters and Warnings	Tasneem Hussain Pharmacist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Data Inactivation	Vikas Arora Pharmacist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Data Removals and Flags	Tasneem Hussain
Downstream Effects	Leyla Rahjou-Esfandiary Lead Consumer Safety Officer DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 4
Recent Automated Validation Rules	Lalnunpuii Huber Technical Information Specialist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Case Studies	Julian Chun Pharmacist DRLB \| DLRUD \| OUDLC \| OC \| CDER \| FDA
Q&A Discussion Panel	Lalnunpuii Huber, Julian Chun, Yajun (Jason) Tu, David Mazyck, Soo Jin Park, Tasneem Hussain, Vikas Arora, Leyla Rahjou-Esfandiary

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

This conference is intended to provide basic instruction in the registration and listing policy and process for those who are new to this regulatory program as well as offer regulatory professionals more in-depth information on issues and current events affecting Drug Registration and Listing. FDA 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 focused on 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 COVERED

Explaining the latest proposed rule on the National Drug Code (NDC).
Learning about the current automated validation rules for registration and listing submissions.
Providing accurate registration and listing data to avoid submission errors, deficiency letters, manual overrides, and more.

LEARNING OBJECTIVES

Explain who must register and list.
Provide an overview to FDA’s registration and listing compliance program.
Explain how the strength conversion is calculated in listing SPLs.
Describe the formats and segments of the National Drug Code (NDC).

U.S. Food and Drug Administration

Event Title

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023

September 28, 2023

ABOUT THIS EVENT

INTENDED AUDIENCE

TOPICS COVERED

LEARNING OBJECTIVES

FDA RESOURCES