Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 September 28, 2023

Conference | Virtual

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• Date: September 28, 2023
• Time: 8:45 a.m. - 4:45 p.m. ET

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Topics & Presentations	Speakers
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 1
Keynote.pdf	Jill Furman, JD Director Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) | FDA
How to Submit an Establishment Registration.pdf	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).pdf	Jose Cabrera Information Technology Specialist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Establishment Registration Renewal, Updates, and De-Registration.pdf	Regie Samuel
U.S. Agents and Official Contacts.pdf	Jose Cabrera
CDER Direct Labeler Code Request Demo.pdf	Soo Jin Park LCDR, USPHS Regulatory Officer DRLB | DLRUD | OUDLC | OC | CDER | FDA
Who Will Be Assigned a Labeler Code and Who Won’t.pdf	Laurie Simonds, GWCPM Technical Information Specialist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Labeler Code Inactivation and Reactivation.pdf	Lalnunpuii Huber Technical Information Specialist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Updates, Mergers, and Acquisitions.pdf	Laurie Simonds
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 – Part 2
CDER Direct Drug Listing.pdf	Troy Cu Technical Information Specialist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Listing a Combination Product.pdf	Troy Cu
Strength Conversion in Drug Listing.pdf	Leyla Rahjou-Esfandiary Lead Consumer Safety Officer DRLB | DLRUD | OUDLC | OC | CDER | FDA
Listing Updates and Delisting.pdf	Yogesh Paruthi Consumer Safety Officer DRLB | DLRUD | OUDLC | OC | CDER | FDA
Blanket No Change Certification.pdf	Vikas Arora Pharmacist DRLB | DLRUD | OUDLC | OC | CDER | FDA
503B Registration and Product Reporting Using CDER Direct.pdf	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.pdf	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.pdf	David Mazyck Consumer Safety Officer DRLB | DLRUD | OUDLC | OC | CDER | FDA
Format of the National Drug Code.pdf	Julian Chun Pharmacist DRLB | DLRUD | OUDLC | OC | CDER | FDA
NDC Assignment to Drugs.pdf	Soo Jin Park LCDR, USPHS Regulatory Officer DRLB | DLRUD | OUDLC | OC | CDER | FDA
Untitled Letters and Warnings .pdf	Tasneem Hussain Pharmacist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Data Inactivation.pdf	Vikas Arora Pharmacist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Data Removals and Flags.pdf	Tasneem Hussain
Downstream Effects.pdf	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.pdf	Lalnunpuii Huber Technical Information Specialist DRLB | DLRUD | OUDLC | OC | CDER | FDA
Case Studies.pdf	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

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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).

FDA RESOURCES

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