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DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
Date:7/9/2009

August 11-12 in Philadelphia, PA

Horsham, PA (Vocus) -- The Drug Information Association (DIA), in collaboration with the Generic Pharmaceutical Association (GPhA), PhRMA, and the Consumer Healthcare Products Association (CHPA), will host eDrug Listing and Establishment Registration--FDA and Industry: Overview and Lessons Learned on SPL (August 11-12; Philadelphia, PA)

The FDA Amendments Act (FDAAA) mandated the requirements for electronic drug establishment registration and drug product listing. FDA has adopted the use of extensible markup language (XML) files in a standard structured product labeling format as the standard format for the exchange of drug establishment registration and drug product listing information. Featured topics will include:

 
  • Lessons learned from the electronic registration/drug product listing pilot
  • Validation rules applied by FDA
  • Nuances of SPL lifecycle management, including findings from the electronic listing pilot and early production submissions.
  • SPL Release 4 terminology
  • Product listing and establishment registration for various complex scenarios (e.g., export only products, product kits, etc.)
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DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
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