With the shift to working from home, changing daily priorities, and resources during the COVD-19 pandemic, regulators have or are making transitions to ease the stress without losing valuable data that may contribute to the treatment of COVID-19 or interrupting clinical trials. The pace at which the information on COVID-19 itself appears is so fast; […]
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.
Blogs from this Author
Pharmacovigilance During COVID-19: Finding the Best Information
There is no question that the pandemic COVID-19 has transformed life as we know it today. We are now operating in a different pharmacovigilance (PV) paradigm, adapting as we move daily. While patient safety remains the first priority, AEs will continue to come in for processing, and daily PV activities will continue. New therapeutic information […]
MedDRA 23.0 – March Madness for the New Release
Each year in March (and September), we eagerly await the new releases of the MedDRA dictionary, hoping that any suggestions we have provided during the year were accepted. We also know that a significant dictionary change can be a bit much during a busy time. MedDRA 23.0 will be released on March 1, 2020. In […]
Top Five Questions about PV Hawk and a Webinar Wrap-Up
Earlier in the month, we introduced an innovative solution for PV Safety Surveillance in a webinar. We even had 22 reasons to attend the webinar. If you found yourself answering yes to things like “I hate the flat reports we get that makes it impossible to interpret the data” then revisiting the webinar recording is […]
22 Reasons To Attend Thursday’s Pharmacovigilance Surveillance Webinar
The challenge with all pharmacovigilance and safety surveillance is that it’s quite complicated. There is a lot of data and very few technical solutions that make analyzing safety data relatively simple. That’s where Perficient comes in. Join me, Kari Blaho-Owens, Ph.D., Director of Pharmacovigilance and Safety, Perficient, on February 6, 2020, at 10 AM CT, […]
Drug-Induced Live Injury – Causes, Identification and Risks
This afternoon at the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C, we are digging down into one of the cruxes of surveillance in pharmacovigilance (PV); drug-induced live injury (DILI). Vicky and I attended a panel consisting of hepatic experts sharing information on the latest drug-related DILI and the best way to detect […]
Opening Remarks from the DIA Pharmacovigilance Strategies Conference
Today marks the beginning of the DIA Pharmacovigilance and Risk Management Strategies Conference in Washington, D.C., and the aura around the event is incredible. Industry speakers, short courses, hot topics, networking, education, and round-table discussions. All dedicated to enhancing the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs. The Perficient team is […]
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 […]
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 […]
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 […]
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 […]
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 […]