Bharatbook.com Medical Affairs: Evolving With the Compliance Environment (ph74)

Medical Affairs: Evolving with the Compliance Environment (PH74) :

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.

Profiled Companies

Abbott Labs
Amgen
AstraZeneca
Baxter
Baxter Healthcare
Bayer
Berlex

Table of Contents :

EXECUTIVE SUMMARY

Figure E.1: Percent of Companies with Medical Affairs Operations Per Country/Region
Figure E.2: Staffing Consistencies

MEDICAL AFFAIRS STRUCTURE, ACTIVITIES AND OUTSOURCING TRENDS

Adapting to New Times: Medical Affairs Structure
Figure 1.1: Percent of Companies with Global Medical Affairs Functions
Figure 1.2: Medical Affairs Organizations
Figure 1.3: Medical Affairs Alignment
Figure 1.4: Medical Affairs Reporting Relationships
Figure 1.5: Medical Affairs Leadership

Outsourcing: Filling Important Gaps

Figure 1.11: Percent of Companies That Outsource Medical Affairs
Figure 1.12: Outsourcing Spends for Medical Affairs in 2005
Figure 1.13: Breakdown of Outsourcing Spending by Activity

RESOURCING SUCCESSFUL MEDICAL AFFAIRS DEPARTMENTS

Medical Affairs Spending

Figure 3.1: Medical Affairs Funding Sources
Figure 3.2: Funding Sources for Global and Affiliate Medical Affairs Teams
Figure 3.3: Funding Sources Medical Affairs Sub-Teams
Figure 3.4: 2005 Medical Affairs Budgets Per Company
Figure 3.5: Percent of Medical Affairs Spending by Activity Per Company

MEDICAL AFFAIRS STAFFING

Figure 3.61: 2005 Medical Affairs Headcounts Per Company
Figure 3.62: Percent of Medical Affairs Staffing by Activity Per Company
Figure 3.63: Average Medical Affairs Staffing by Activity
Figure 3.64: Thought Leader Management/MSL Program Headcounts
Figure 3.65: Medical Publications Headcounts
Figure 3.66: Research/Clinical Operations Headcounts
Figure 3.67: Medical Education Headcounts

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