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Structured Product Labeling (SPL) Preparing for FDA Electronic Drug Registration and Drug Listing

29 - 30 October 2008, Philadelphia, PA, United States


Introduction
The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information.

KEY TOPICS
• Electronic drug establishment registration and listing SPL
• Data Universal Numbering System (D-U-N-S®)
• Electronic Submissions Gateway (ESG)
• SPL reference documents
• SPL lifecycle management
• Listing data elements/Terminology
• Transitioning from paper to electronic.

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Venue
Sheraton Philadelphia City Center

Sheraton Philadelphia City Center, 17th and Race, Philadelphia, PA, 19103, United States

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Organised by
Drug Information Association
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