Conference | Virtual
Event Title
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
September 28, 2023
Event Title
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
- Date:
- September 28, 2023
- Time:
- 8:45 a.m. - 4:45 p.m. ET
| 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 |
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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