The corruption risks for companies and individuals engaged in business outside the United States have received a tremendous amount of attention in the last ten years. The pharmaceutical industry is uniquely positioned to be exposed to such risks and potential FCPA enforcement actions. This risk and exposure is, in large part, due to the industry’s regular contact with healthcare professionals and customers considered to be “foreign government officials” under the FCPA. This article explores some of the common interactions between pharmaceutical manufacturers and foreign government officials as well as the increasing involvement of third parties to market and sell pharmaceutical products.
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In The Headlines
A New “Quality System” Training Approach for Sales Reps Creates a “One-Stop” Resource for Achieving Commercialization Compliantly
Ilyssa Levins | Center for Communication Compliance (CCC)
The concept of a “Quality System” has been around for quite some time. However, what’s new is its application to compliance within the marketing sector of the pharmaceutical industry. Do sales representatives always know what to do or say when facing sensitive situations? Are they aware of the new or revised laws and regulations?
Imagine a compliance program that ensures sales representatives know what to do or say with clarity when facing sensitive situations. One in which reps understand the way new or revised laws and regulations or [promotional] violation letters directly impact their interactions with HCPs. And where compliance support for tricky situations is accessible 24/7.
Continue reading "A New “Quality System” Training Approach for Sales Reps Creates a “One-Stop” Resource for Achieving Commercialization Compliantly"
Topic of Discussion
Dr. Niels Erik Hansen|ARxIUM
Recent news of a $200 million fund to compensate victims of the bankrupt New England Compounding Center (NECC) is an extreme example of how expensive manual compounding errors can be. Contaminated compounds produced by NECC were linked to a 2012 meningitis outbreak that killed 64 people in 20 states and sickened more than 750.
But compounding errors don’t have to result in multi-state disease outbreaks to be costly. In fact, a single compounding error can cost a hospital tens of thousands of dollars (or more) if it causes an adverse patient reaction. Research has found automated compounding technology, such as the RIVA system, can help reduce costs by eliminating errors. Automation also reduces the cost-per-dose of medication. A closer look at costs reveals some compelling facts.
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A UL EduNeering Sponsored Article
The whitepaper for this article is available for free download here: “Top Seven Risks to Consider When Selecting a Life Science LMS”.
Life Science companies operate in a highly regulated industry. With risk mitigation core to their DNA, they must be careful when evaluating an enterprise Learning Management System (LMS) or a Talent Management System (TMS) used in GxP areas. It is critical that these systems meet data integrity standards and are validated against the stringent requirements of 21 CFR Part 11 and EU Annex 11.
We find that, as companies look to harmonize systems and bring in enterprise applications to manage both employee development and qualification training, these projects are increasingly influenced or guided by IT and HR. Since these organizations are not as versed in US and international regulatory requirements and since their training programs do not require a validated platform, the project teams they lead are bringing in vendors and systems that do not support the GxP requirements of their organization. This is putting a lot of pressure on QA to “relax” their standard of validation, putting their organization at a data integrity risk.
Continue Reading: “Performance Gaps in LMS Functionality May Lead to Critical Risk for Life Science Companies.”