Monitoring and Ensuring Pharmaceutical Compliance (PH113)
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- Published 2008
- 104 Pages
- 300+ Metrics
- 50+ Charts and Diagrams
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Build a team and organizational structure to track your company's pharmaceutical compliance activities.
Pharmaceutical compliance is at the forefront of everyone's minds across the pharma and life sciences industries. Companies face the threat of staggering fines and crippling scrutiny from regulatory bodies. A growing level of public distrust negatively impacts corporate reputations. The evolving regulatory environment has dramatically affected companies' organizational structures and practices. In fact, compliance concerns have driven some the industry's most influential companies to reexamine — and sometimes reinvent — 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.
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Companies Included in Pharmaceutical Compliance Research
- Allergan
- Bayer
- Biogen Idec
- CV Therapeutics
- Dyax
- EMD Serono
- GlaxoSmithKline
- Janssen-Ortho
- Johnson & Johnson
- Pfizer
- Novartis
- Schering-Plough
- Upsher-Smith
- Two large biotechnology companies
- ...plus more
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Pharmaceutical Compliance Metrics
- 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
- Individual companies' compliance structures
- Company Q'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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Pharmaceutical Compliance Report Sample
The following excerpts are from Chapter 2: Monitoring and Ensuring Compliance. The full report provides detailed findings on compliance training and internal communication methods.
Compliance Training
While the level of responsibility that compliance teams hold over training varies, almost all compliance groups play some role in the training of other functions. Some groups develop and deliver all training to do with compliance, whereas others simply provide input to the training done by the departments themselves. Figure 2.1 [chart appears in full report] shows that 81% of compliance groups provide at least some training to other functions, while only 19% do not provide any training to other departments.
Figure 2.2 [chart appears in full report] illustrates the share of compliance departments that deliver training to specific functions. For instance, 71% of compliance departments conduct training for individuals in marketing. Over half of compliance teams train other functions in their companies, such as medical affairs, business development, regulatory, legal and R&D...
Maintaining Open Lines of Communication
Compliance executives agree that open lines of communication, whether formal or informal, go a long way in furthering the ongoing compliance efforts at their companies. Whereas tools like reference manuals are certainly useful, MSLs and other staff benefit more fully when they also have the opportunity to ask questions of their superiors or of the entire pharmaceutical compliance organization. Compliance leaders should foster a culture of openness by encouraging questions and feedback and by directing various department leaders to do so as well. With this in mind, departmental personnel will not be hesitant to sound questions off of their peers and leaders, and they will ultimately make fewer blunders.
One way to maintain open communication on compliance topics is to hold frequent meetings. Such meetings need not be companywide or even directed by the compliance department, but they should include at least some representation by the compliance department. For instance, a company's vice president of medical affairs would do well to hold quarterly question-and-answer sessions for medical science liaisons. The sessions should have at least one compliance officer present to ensure that compliance-related statements are accurate.
Aside from meetings, which are sometimes difficult to arrange and orchestrate, other excellent ways to keep communication lines open are...
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