Kari Blaho-Owens, Author at Perficient Blogs
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Kari Blaho-Owens

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Solving a Complex Problem with a Fit-for-Purpose in PV Analytics

Analytics (i.e., using math and other systematic approaches to bring understanding to pharmacovigilance) data can have its own adverse event: a strong sensation of nausea if you haven’t had the opportunity to put into place a sensible, compliant solution that is the right fit for your organization. You can even have an on-demand solution, when […]

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MedDRA Upgrades: 4 Clarifications

We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017. Our clients often have questions about upgrading their […]

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Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

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