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Kari Blaho-Owens

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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Improving Pharmacovigilance Surveillance With Real-Time Tools

New codes of practice and guidelines in the EU and US hold marketing authorization holders (MAH) to higher standards for the surveillance of adverse event (AE) and product quality complaint (PQC) data. While good pharmacovigilance (PV) and safety surveillance is a required practice, companies agree that having more and better insight into their data can […]

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What The Three Little Pigs Taught Me About Pharmacovigilance Analytics

The pain points and the reality of safety surveillance within a sound risk management program are daunting. The expanded pharmacovigilance analytics (PV) landscape, geography, product type, and most importantly, regulatory changes are important considerations. Like the plague, risk management and drug surveillance panic spread quickly. How to keep up and have a meaningful understanding of […]

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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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