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

The Drug Information Association (DIA), in collaboration with Rosetta Stone 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 Rosetta Stone V3 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.) The SPL Vendor Showcase will provides an opportunity for attendees to evaluate a number of currently available services and tools as they are used to produce an equivalent final product. During this session, participating vendors will demonstrate their services and/or tools and present their results. The SPL Live QA will allow attendees to ask key FDA representatives about electronic establishment registration and product listing regulatory content, SPL technical content, or the ESG submission process This one-of-kind event is the only opportunity to hear industry and FDA representatives discuss best practices for electronic establishment registration and product listing, says Program Co-chair Therese Brunone, MS, Assistant Director, Global Regulatory Operations, GlaxoSmithKline.About the Drug Information Association (DIA)DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its Rosetta Stone Chinese domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Rosetta Stone Languages Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team.