医薬品の適合性に関する監視と確認

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.

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