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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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Source: PRWeb
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DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
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