Conference on Electronic Drug Registration and Listing
U.S. Food and Drug Administration sent this bulletin at 10/06/2021 01:42 PM EDT
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October 6, 2021
Dear International Colleague,
The Office of Global Policy and Strategy would like to call your attention to an upcoming free conference being offered by the FDA's Center for Drug Evaluation and Research, Small Business and Industry Assistance program.
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct OCTOBER 13, 2021 | 8:45 AM - 4:00 PM ET This conference is free
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
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
ABOUT
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.
CONTINUING EDUCATION
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been:
pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
