Medical Affairs: Evolving with the Compliance Environment

Medical affairs departments are suffering from the latest round of regulatory scrutiny. With the regulatory environment constantly changing, medical affairs teams must frequently adapt just to keep up. Recent regulatory guidelines, such as the OIG’s Compliance Program Guidance, continuously force pharmaceutical companies to reevaluate their daily operations to ensure they remain compliant. The industry is also considering the effects that Medicare Part D will have on medical affairs teams. Industry-leading companies react, and sometimes overreact, to new regulations and guidelines that frequently cause organizational disruption in their medical affairs functions.
Cutting Edge Information has developed this study to research pharmaceutical companies’ medical affairs functions - and what makes them successful in the face of a constantly changing compliance environment. Medical Affairs: Evolving with the Compliance Environment examines the inner workings of pharmaceutical medical affairs departments. From budget allotments to departmental and individual activity staffing levels, this report details the strategies and tactics of some of the industry’s top medical affairs groups.

Medical Affairs: Evolving with the Compliance Environment analyzes the practices of some of the industry’s top medical affairs departments to provide the steps medical affairs departments must take to make their functions more integral pieces of the overall company picture. The report provides the tools that medical affairs leaders need to improve their departments by comparing their spending, staffing, structure, activities and compliance strategies to gain a competitive advantage over top pharmaceutical companies.

The report makes its case with metrics and techniques for managing the medical affairs function:

Structure and Activities - Learn how industry leaders have reorganized their medical affairs departments and reassigned responsibilities to remain compliant
Compliance Strategy and Globalization - The increased scrutiny has led some companies to implement global standards to remain compliant across all their medical affairs teams
Budgets, Staffing and Training - Analysis of current medical affairs resource allocation, including budget and staffing data for thought leader development, clinical operations, medical education and medical publications. Also, analysis on how companies have implemented more rigid training for their medical affairs personnel to recognize potential compliance issues and adapt their operations to avoid regulatory scrutiny

Pages: 199

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