Monitoring and Ensuring Pharmaceutical Compliance

Table of Contents

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