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市場調査レポート
医薬品の適合性に関する監視と確認
Monitoring and Ensuring Pharmaceutical Compliance
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当商品の販売は、2012年05月08日を持ちまして終了しました。
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
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