Event Date/Time: May 16, 2005 End Date/Time: May 17, 2005
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Description

Traditionally, a medical affairs department provides scientific support for a pharmaceutical company’s marketing efforts with the caveat that the basis for this support be independently conceived and not in anyway influenced by a marketing campaign. However, increasing scrutiny over such matters as the duties of medical science liaisons, the dissemination of information on off-label use, CME requirements and medical ghostwriting — all matters within the traditional purview of medical affairs — have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding last year’s Neurontin settlement illustrate this problem and the substantial financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

The OIG Guidance of 2003 was an attempt to clarify and delineate the respective roles and duties of medical affairs and sales and marketing in gray areas, yet confusion remains. Does your company have the necessary policies and procedures in place to ensure that the independence and integrity of its medical affairs department remain above reproach?

As counsel to, executive or compliance officer for a medical affairs department of a pharmaceutical company, you need a complete understanding of the latest legal and regulatory developments affecting medical affairs today. This cutting edge American Conference Institute event will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel, medical affairs specialists and compliance officers as well as expert attorneys. They will provide many valuable insights.

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