Top Article LiveFree Articles Directory

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

for more information, please visit our web site :

http://www.bharatbook.com/detail.asp?id=52014