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Activity Outline
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
September 28, 2023
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
September 28, 2023
Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov), Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Description
FDA will provide a demonstration on how to submit establishment registration and drug listing data using CDER Direct. In addition, FDA will discuss an overview on registration and listing regulatory requirements and compliance framework. Finally, FDA will illustrate best practices through case studies for an interactive learning experience at the end of the day.
References
- Federal Register Revising the National Drug Code Format and Drug Label Barcode Requirements https://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements
- Electronic Registration and Listing Instructions https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions
- Electronic Registration and Listing Compliance Program https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-registration-and-listing-compliance-program
- Strength Conversion in Drug Listing https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/strength-conversion-drug-listing
- Structured Product Labeling Resources https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources
Learning Objectives
- Explain how to submit establishment registration and drug listing data using CDER Direct.
- Provide an overview of FDA’s registration and drug listing compliance program.
- Demonstrate how the drug strength conversion is calculated in listing Structured Product Labeling (SPL)s.
- Describe the formats and segments of the National Drug Code (NDC).
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
This activity is intended for physicians, pharmacists, and nurses.
Agenda
Day 1 September 28, 2023
Day 1 September 28, 2023
| Time | Topic | Speaker |
|---|---|---|
| 8:45 - 9:00 AM EDT | Welcome and Overview |
Brenda Stodart, PharmD, MS, BCGP, RAC Forest Ford, PharmD, R. Ph |
| 9:00 - 9:15 AM EDT | Keynote | Jill Furman, JD |
| 9:15 - 10:00 AM EDT | Registering Your Drug Manufacturing Establishment Using CDER Direct |
Regie Samuel Jose Cabrera |
| 10:00 - 10:45 AM EDT | Requesting a Labeler Code from FDA |
Soo Jin Park, PharmD, MS Laurie Simonds, GWCPM Lalnunpuii Huber |
| 10:45 - 11:00 AM EDT | Break | |
| 11:00 - 12:00 PM EDT | Listing Your Drug Using CDER Direct |
Vikas Arora, PharmD, PMP, RAC Troy Cu Leyla Rahjou-Esfandiary, PharmD Yogesh Paruthi, PharmD |
| 12:00 - 12:15 PM EDT | 503B Registration and Product Reporting Using CDER Direct | Huascar Batista |
| 12:15 - 12:45 PM EDT | Q&A Panel |
Regie Samuel Vikas Arora, PharmD, PMP, RAC Soo Jin Park, PharmD, MS Troy Cu Leyla Rahjou-Esfandiary, PharmD Laurie Simonds, GWCPM Jose Cabrera Yogesh Paruthi, PharmD Lalnunpuii Huber Huascar Batista |
| 12:45 - 1:40 PM EDT | Lunch Break | Not offered for CE |
| 1:40 - 1:45 PM EDT | SBIA Welcome Back & CE Reminders | Forest Ford, PharmD, R. Ph |
| 1:45 - 2:00 PM EDT | OMUFA Updates | Yajun Tu, PhD, PharmD, BCSCP |
| 2:00 - 2:30 PM EDT | National Drug Code |
Soo Jin Park, PharmD, MS David Mazyck Julian Chun, PharmD |
| 2:30 - 3:15 PM EDT | Registration and Listing Compliance Program |
Vikas Arora, PharmD, PMP, RAC Tasneem Hussain, PharmD Leyla Rahjou-Esfandiary, PharmD |
| 3:15 - 3:30 PM EDT | Break | |
| 3:30 - 3:45 PM EDT | Recent Automated Validation Rules | Lalnunpuii Huber |
| 3:45 - 4:15 PM EDT | Case Studies | Julian Chun, PharmD |
| 4:15 - 4:40 PM EDT | Q&A Panel |
Vikas Arora, PharmD, PMP, RAC Soo Jin Park, PharmD, MS David Mazyck Tasneem Hussain, PharmD Leyla Rahjou-Esfandiary, PharmD Julian Chun, PharmD Lalnunpuii Huber Yajun Tu, PhD, PharmD, BCSCP |
| 4:40 - 4:45 PM EDT | SBIA Closing | Forest Ford, PharmD, R. Ph |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 6.5 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 6.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-064-L04-P for 6.50 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 6.50 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Arora, Vikas, PharmD, PMP, RAC, Regulatory Project Manager, Food and Drug Administration - nothing to disclose
- Batista, Huascar, Senior Regulatory Science Advisor, FDA CDER Office of Compliance - nothing to disclose
- Cabrera, Jose, Technical Information Specialist, FDA - nothing to disclose
- Chun, Julian, PharmD, Pharmacist, FDA - nothing to disclose
- Cu, Troy, Technical Information Specialist, FDA - nothing to disclose
- Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
- Furman, Jill, JD, Director, CDER Office of Compliance - nothing to disclose
- Huber, Lalnunpuii, Technical Information Specialist, FDA - nothing to disclose
- Hussain, Tasneem, PharmD, Pharmacist, FDA, Office of Compliance - nothing to disclose
- Mazyck, David, Consumer Safety Officer, FDA/ CDER/ OC/OPRO/DRLS - nothing to disclose
- Park, Soo Jin, PharmD, MS, Senior Regulaory Officer, FDA/CDER/OC/OUDLC - nothing to disclose
- Paruthi, Yogesh, PharmD, Consumer Safety Officer, FDA - nothing to disclose
- Rahjou-Esfandiary, Leyla, PharmD, Lead CSO, FDA - nothing to disclose
- Samuel, Regie, Technical Information Specialist, Food and Drug Administration - nothing to disclose
- Simonds, Laurie, GWCPM, Technical Information Specialist, U.S. Food & Drug Administration - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
- Tu, Yajun, PhD, PharmD, BCSCP, Program Management Officer, FDA - nothing to disclose
Planning Committee
- Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
- Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose
CE Consultation and Accreditation Team
- Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
- Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 50% of the activity.
Must attend 50% of the activity.
U.S. Food and Drug Administration