Speaker(s): Barbara Fanelli, Associate Vice President, Regulatory Labeling Sanofi-Aventis U.S. LLC
Speaker Bio: Barbara Fanelli is an Associate Vice President, Regulatory Labeling at Sanofi-Aventis U.S. LLC, where she is responsible for coordination of the development, preparation, review and approval of labeling for pharmaceutical products, including preparation of Core Data Sheets, US and European prescribing information and patient product information. Her experience includes creation of labeling for new products, including pharmaceutical and biological prescription products as well as OTCand generic labeling, updating labeling for marketed products, assuring labeling compliance worldwide, quality assurance of production and testing procedures for biological and sterile pharmaceutical products, development of product specifications, testing procedures, stability protocols, and test implementation. Prior to joining sanofi-aventis she was Senior Director of Worldwide Product Labeling at Merck & Co., Inc. She also is an Associate Adjunct Professor at Temple University School of Pharmacy, where she teaches in the QualityAssurance and Regulatory Affairs Masters Program. Ms. Fanelli received her MS in pharmaceutics from Temple University and her BS in Biology from St. Francis University in Loretto, Pennsylvania.
Time: 5:00-6:00: Cocktails and Networking 6:00-7:30: Dinner Buffet 7:30-9:00: Presentation
Event Abstract: Are you interested (or required to be interested) in the "new and improved" worldwide standards and requirements for product labeling? Well, we are, and we've invited a subject matter expert, as well as an engaging lecturer, to help refresh our understanding of the subject.
Barbara Fenelli's lecture will be a discussion of the development of worldwide product labeling and how the labeling development parallels the drug development process. She will describe how good labels include the required information about the safe and effective use of the product and can include some of the other uses, too.
Barbara will also provide an overview of the labeling requirements in the major regions, e.g., United States, European Union, showing similarities and differences between the regions. She will conclude with her analysis of some recent changes in regulations and their impact on labeling.
Barbara will specifically address: - Concurrent label and drug development - Purposes of labeling - Regional requirements for labeling - Recent labeling regulatory changes
And she will gladly accept questions from the attendees.
