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Monitoring and Ensuring Pharmaceutical Compliance (PH113)

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Published 2008
104 Pages
300+ Metrics
50+ Charts and Diagrams

  Overview

Companies Metrics Content

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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

 


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