Abstract
Monitoring and Ensuring Pharmaceutical Compliance (PH113)
Compliance is at the forefront of pharma companies' minds today. Companies
face the threat of staggering fines and increased scrutiny from regulatory
bodies. A growing level of public distrust of the industry also carries a
negative effect on companies' reputations. These events have created a new
regulatory environment that has dramatically affected companies'
organizational structures and practices. In fact, the industry' s most
influential companies have reexamined-and sometimes reinvented-the way they do
business.
This new landscape thrusts compliance groups into the center of the action.
Compliance teams have gained additional resources and a stronger tie to
executive leadership. But with this increased power comes challenges in
communicating regulatory changes, in training and testing employees, and in
ensuring compliance across an organization.
This report examines the current state of compliance management at some of the
pharmaceutical industry' s top companies. It looks at metrics and strategies
surrounding three aspects of compliance success:
- Structure, Headcounts and Investment - Provides up-to-date
structuring strategies, headcounts and investments of top compliance groups
- Monitoring and Ensuring Compliance - Details companies' strategies
regarding monitoring, training, testing, documentation, firewalls, and much
more
- Activities and Challenges - Examines the focus and reach of top
compliance functions. Also looks at the impact and reactions to some recent
regulations. Finally, survey respondents rate the challenges facing compliance
efforts moving forward.
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