Pharma Labeling Compliance
Organization: marcus evans
Venue: Onyx Hotel - a Kimpton Hotel
|Event Date/Time: Mar 20, 2013||End Date/Time: Mar 21, 2013|
Designing a product label is a long and complex process, from the amount of time that is needed, to creating a label that is compliant with the current FDA regulations. The marcus evans Pharma Labeling Compliance Conference will explore new ways to overcome these challenges by analyzing the current FDA timelines and regulations that will impact the life cycle of a label as well as will look at one of the hottest topics, Structured Product Labeling (SPL), evaluating how companies are converting their word documents into XML format, and discussing the benefits of Downstream Structured Product Labeling. This conference will then assess the way the product label is designed, how it will meet pharmacovigilance requirements, and be able to track the label’s global compliance.
Key Speakers Include:
Colleen A. McGraw Director, Labeling & Product Communications, Vertex Pharmaceuticals Una Ortell, M.Sc. RAC Global Head, Labeling & Promotion, Regulatory Affairs, Takeda Global Research & Development Center Inc. Antoinette Eber-Roe Director, Regulatory Affairs, Label and Ad Promo Operations & Compliance, Abbott Laboratories Patricia A. Walsh Director, Global Labeling Operations, Bristol-Myers Squibb Amy Ebel, PharmD Director, Global Regulatory Affairs, Labeling Strategy, GlaxoSmithKline