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UID:1905@azbio.org
DTSTART;TZID=America/Phoenix:20240912T054500
DTEND;TZID=America/Phoenix:20240912T134500
DTSTAMP:20240712T155733Z
URL:https://www.azbio.org/events/fda-electronic-drug-registration-and-list
 ing-edrls-using-cder-direct-2024
SUMMARY:FDA: Electronic Drug Registration and Listing (eDRLS) Using CDER Di
 rect - 2024 -  - 12 Sep 24 05:45
DESCRIPTION:\nDate: September 12\, 2024\nTime: 8:45 AM - 4:45 PM ET (5:45 A
 M - 1:45 PM AZ/PDT)\nLearn More and Register\nABOUT THIS CONFERENCE (Hoste
 d by CDER SBIA)\n\nThis annual event will provide:\n\n 	A demonstration on
  how-to submit establishment registration and drug listing data using CDER
  Direct.\n 	An overview on registration and listing regulatory requirement
 s and compliance framework.\n 	Case studies for an interactive learning ex
 perience at the end of the day.\n\nINTENDED AUDIENCE\n\n 	Regulatory scien
 ce and regulatory affairs professionals working on establishment registrat
 ion and drug listing submissions and data compliance.\n 	Consultants and v
 endors assisting industry with Structured Product Labeling (SPL) submissio
 ns to FDA.\n 	Healthcare professionals using drug listing data and downstr
 eam databases to access prescribing and labeling information.\n 	Foreign d
 rug manufacturers and importers that manufacture and import drugs for US c
 ommercial distribution.\n\nTOPICS\n\n 	Explaining the proposed rule on the
  National Drug Code (NDC) format.\n 	Providing accurate registration and l
 isting data to avoid submission errors\, deficiency letters\, manual overr
 ides\, and more.\n 	Discussing drug amount reporting requirements.\n\nLEAR
 NING OBJECTIVES\n\n 	Explain who must register and list.\n 	Provide an ove
 rview to FDA’s registration and listing compliance program.\n 	Describe 
 the formats and segments of the National Drug Code (NDC).\n 	Discuss OTC d
 rug listing requirements and its relation to OTC Monograph Drug User Fee P
 rogram (OMUFA) assessment.\n
CATEGORIES:Conventions and National Events
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