Medical Affairs

Venue: New York City

Location: New York City, New York, United States

Event Date/Time: Nov 11, 2004
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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 — matters,all within the purview of medical affairs — have raised questions about the real borders between medical affairs and sales and marketing. The issues surrounding the recent Neurontin settlement illustrate this problem and the substantive financial and punitive consequences that result when the duties of medical affairs and sales and marketing are improperly co-mingled.

Last year’s OIG Guidance 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, 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 insights on:

The impact of the OIG guidance in defining the duties of medical affairs
The proper role of medical affairs in Pre-Phase IV studies
How the OIG guidance and PhRMA Code have impacted post-marketing studies
Effective risk management techniques in MI/PI communications
Streamlining procedures for adverse events reporting
The FDA’s reaction to the EU’s push for international harmonization of good pharmacovigilance practices
Proper re-imbursement structures for physician-consultants
The role of MSLs with respect to the dissemination of information regarding off-label use and other compliance issues
Criteria for the authorship of medical articles
Strategies for avoiding conflicts of interest for industry sponsored v. non-industry sponsored CME events