This report examines the current state of compliance management at some of the pharmaceutical industry’s top companies.
Online PR News – 27-October-2009 – – 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 :
The following excerpts are from Chapter 2: Monitoring and Ensuring Compliance. The full report provides detailed findings on compliance training and internal communication methods.
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 compliance team. 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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