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How to Make a Successful Electronic Registration and Listing Submission: NDC, Regulatory Compliance, and Technical Requirements
Session Chair(s)
Leyla Rahjou-Esfandiary, PharmD
Lead CSO, Office of Compliance, CDER
FDA, United States
This session focuses on all disclosable information related to drug establishment registration and drug listing requirements from the legal and technical perspective. It also discusses the FDA's current position on National Drug Code (NDC), its assignment to CDER-regulated products, and its use inside and ouside of FDA.
Learning Objective : Describe new legal requirements for electronic registration and listing; Identify FDA's current position on the national drug code (NDC) and its assignment to CDER drugs; Discuss new automated validation rules for electronic drug listing submissions.
Speaker(s)
Complying with Registration and Listing Requirements: CDER Perspective
Soo Jin Park, PharmD, MS
FDA, United States
Regulatory Officer, Office of Compliance, CDER
SPL Data Standard Perspective: Electronic Registration and Listing
Lonnie D. Smith
FDA, United States
Policy Analyst, Office of the Chief Scientist, Office of Health Informatics, OC
Industry Perspective
Thomas R. Bizzaro, RPh
First Databank, Inc. (FDB), United States
Vice President, Health Policy and Industry Relations
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