Monitoring and Ensuring Pharmaceutical Compliance

Publication Date	March 2008
Publisher	Cutting Edge Information
Product Type	Report
Pages	104
ISBN Number	not applicable
Product Code	CUT00020

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Summary

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.

Content

Metrics Included in Report
Compliance Functions' Years in Existence
Dedicated Compliance Management
Department Structures: Centralized vs. Decentralized
Compliance Group Reporting Lines
Global Compliance Management
Level of Executive Leading Compliance
Compliance Group Staffing in Ftes
Ftes to Be Added to The Compliance Group over The next Year
- Company A's Compliance Structure
- Company Q's Compliance Structure
- Company I's Compliance Structure
- Company F's Compliance Structure
- Company H's Compliance Structure
Compliance Department Budgets
Percentage of Compliance Groups Providing Training to Other Functions
Percentage of Compliance Departments Delivering Training to Specific Functions
Functions Trained by Compliance Departments
Compliance Team Involvement in Training
- Training Hours Provided to Marketing
- Training Hours Provided to Business Development
- Training Hours Provided to Market Research
- Training Hours Provided to Sales
- Training Hours Provided to Regulatory
- Training Hours Provided to Legal
- Training Hours Provided to R&D/Clinical Operations
- Training Hours Provided to Pharmacovigilance
Compliance Training Test Methods
Benefits of Documentation
Average Compliance Department Activities Allocation
Percentage of Compliance Groups Providing Training
Functions Provided Training by Compliance Teams
Activities Allocation by Company
Percentage of Compliance Groups Performing Specific Activities
Rating Compliance Challenges
- Impact of OIG Guidelines
- Impact of Uniform Requirements from International Committee of Medical Journal Editors
- Impact of Good Publication Practices Guidelines (GPP)
- Impact of CONSORT Statement
- Impact of Food and Drug Administration Modernization Act (FDAMA)
- Impact of PhRMA Code
- Impact of Good Clinical Practices (GCP)
Function to Be Most Affected by Compliance Issues over The next Two Years
Trend: Moving toward Centralized Structure