Barbara Fanelli, MS

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Regulation of Product Labeling and Drug Information

As the U.S. director of Labeling at Aventis, Barbara Fanelli has extensive experience coordinating the development, preparation, review and approval of labeling for pharmaceutical and biological ethical products and OTC products and generics. She is well versed in Headquarters Core Data Sheets and Patient Information, U.S. Package Circulars and Patient Product Information, and European Union Physicians’ Circulars and Package Leaflets. She has updated labeling for marketed products, reviewed labeling from worldwide sites to assure compliance with core products data sheets, overseen QA of production and testing procedures for biological and sterile pharmaceutical products, and developed product specifications, testing procedures and stability protocols and test implementation. Ms. Fanelli received her MS in pharmaceutics from Temple and her BS in biology from St. Francis College. She was the Senior Director of Worldwide Product Labeling at Merck & Co., Inc.

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