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DTSTART;TZID=America/New_York:20260929T084500
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DTSTAMP:20260727T141034Z
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SUMMARY:FDA’s Drug Registration and Listing Workshop: Compliance\, Regulatory and Submission Updates
DESCRIPTION:This SBIA workshop will feature updates from the U.S. Food and Drug Administration (FDA) on establishment registration and drug listing submissions\, including current validation rules\, evolving regulatory requirements\, and compliance considerations. Attendees will have the opportunity to learn about recent developments affecting these processes and hear discussions on strategies for addressing drug amount reporting requirements. \nThe program will also examine FDA’s final rule on Revising the National Drug Code Format and Drug Label Barcode Requirements and its potential impact on future National Drug Code (NDC) formatting. The workshop will conclude with a panel discussion featuring subject matter experts\, providing attendees with an opportunity to explore key regulatory changes\, discuss implementation considerations\, and gain additional insight into current compliance and reporting expectations. \nIntended Audience \n\nRegulatory science and regulatory affairs professionals working on establishment registration and drug listing submissions and data compliance.\nConsultants and vendors assisting industry with Structured Product Labeling (SPL) submissions to FDA.\nHealthcare professionals using drug listing data and downstream databases to access prescribing and labeling information.\nForeign drug manufacturers and importers that manufacture and import drugs for US commercial distribution.\n\nTopics Covered \n\nProviding the latest updates for submitting accurate registration and listing data to avoid submission errors\, deficiency letters\, manual overrides\, and more.\nDiscussing drug amount reporting requirements and compliance outcomes.\nExplaining the final rule Revising the National Drug Code Format and Drug Label Barcode Requirements and the future format of the NDC.\n\nContinuing Education (CE) \nReal-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. \nThis course has been pre-approved by: \n\nRAPS 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.\nSOCRA 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.\nSQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.\nACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.\n\nVisit the event page for more information.
URL:https://about.citiprogram.org/event/fdas-drug-registration-and-listing-workshop-compliance-regulatory-and-submission-updates/
LOCATION:FDA White Oak Campus: The Great Room\, Building 31\, 10903 New Hampshire Avenue\, Silver Spring\, MD\, 20993\, United States
ATTACH;FMTTYPE=image/png:https://about.citiprogram.org/wp-content/uploads/2025/04/fda-logo.png
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