Workshop | Virtual
Event Title
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
October 13, 2021
- Date:
- October 13, 2021
- Time:
- 8:45 a.m. - 4:00 p.m. ET
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Topics & Presentations |
Speakers |
|---|---|
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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address Welcome Remarks from the Director of the Office of Compliance Keynote - Slides FDA Website: Resources Available to You - Slides Drug Establishment Registration 101 – The Basics |
Paul Loebach Don Duggan Regie Samuel Vikas Arora Puii Huber
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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2 Drug Listing 101 – The Basics - Slides
The National Drug Code (NDC): Rules for Assigning and Changing - Slides 503B Human Drug Compounding Outsourcing Facility Registration and Product Reporting 101 – The Basics - Slides Q&A Panel |
Soo Jin Park David Mazyck Troy Cu Regie Samuel |
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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3 OMUFA Fees for Registered OTC Drug Manufacturers - Slides Tips, Techniques, and Common Mistakes with Submissions
Compliance Program - Slides |
Matt Brancazio Tasneem Hussain Troy Cu Paul Loebach |
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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 and Closing Remarks Current Compliance Projects: Submission Troubleshooting Exercise Q&A Panel Closing Remarks |
Tasneem Hussain Leyla Rahjou-Esfandiary Paul Loebach Julian Chun
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Visit CDER Small Business and Industry Assistance Page
KEYNOTE SPEAKER
Paul Loebach
Branch Chief
Drug Registration and Listing Branch
Division of Labeling, Registration and Unapproved Drugs
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance | CDER
ABOUT THIS CONFERENCE
This conference is part of the SBIA Regulatory Education for Industry (REdI) series and 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.
TOPICS COVERED
- Registration and Listing 101: FDA will demonstrate using CDER Direct how to create and submit:
- Establishment Registration and De-Registration
- Labeler Code Request and Update
- OTC and Rx Product Listing and Update
- NDC Reservation
- 503B Compounder Registration and Product Report
- FDA will discuss:
- the structure, use, and future of the National Drug Code (NDC) number
- common errors and issues encountered with submissions
- FDA will provide an overview of:
- the compliance program and process and steps a registrant should take if they receive a deficiency letter.
- the Over-The-Counter Monograph User Fee Program (OMUFA) and how registration is used to calculate fees
FDA RESOURCES
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Drug Registration and Listing Website
- Structured Product Labeling Resources
- CDER Direct Login and links
INTENDED AUDIENCE
- Regulatory affairs professionals working on Registration and Listing or who submit structured product labeling (SPL) to FDA
- Members of pharmaceutical industry who submit Registration and Listing
- Human drug compounding outsourcing facilities
- U.S. Agents for foreign registrants
- Importers and import agents
- Consultants and law firms representing pharmaceutical companies