Thought Leadership Volume 2,  Issue 6   Spring 2007

Cover Page Marketing Cost Disclosures and Prohibitions The Importance of User Requirements Getting the most out of CRM Solutions Sample Data & Off-Label Promotion Upcoming Events Past Issues Credits Welcome to the Spring Edition of Thought Leadership StayinFront, Inc. and Porzio, Bromberg & Newman, P.C. are pleased to share the Spring 2007 issue of Thought Leadership: Sales and Marketing Compliance. Our Spring 2007 Thought Leadership newsletter highlights pending legislation regarding marketing costs associated with healthcare practitioners. We also discuss the practice of off-label promotion and how manufacturers need to establish policies and procedures to prevent this prohibited practice. This issue also takes a look at the importance of solid user requirement specifications when preparing for software implementation and lastly a review of best practices and options associated with training. As always, we hope the information provided in this newsletter is helpful in sorting through compliance issues affecting your business. If you have a perspective or opinion on regulation and compliance you would like to share, or other contributions and comments, please contact Sam Barclay at sbarclay@stayinfront.com or John Oroho at jporoho@pbnlaw.com. Marketing Cost Disclosures and Prohibitions - The New Frontier Is your state one of the fifteen states that may be affected by the new pharmaceutical bills being introduced in the 2007 state legislative sessions? (View) The Importance of User Requirements The GAMP 4 guide to validation is the most widely used, internationally accepted guide for validation of computer systems. Learn the do’s and don’ts of the most critical point of the process. (View) Effective Training Allows Users to Get the Most from Their CRM Solution Customer relationship management (CRM) systems are an invaluable resource to pharmaceutical manufacturers but the value that a CRM system brings to a company depends largely on how well system users have been trained. (View) Can prosecutors use data from sample distribution as evidence of off-label promotion? In an era of increased scrutiny and large settlements, zealous prosecutors will undoubtedly use novel methods to pursue pharmaceutical manufacturers, with off-label promotion in the spot light. (View) StayinFront, Inc. Porzio, Bromberg & Newman