Life Sciences

Overcoming Challenges with a Pharmacovigilance System

Scientists Discussing And Using Computer Software

My last blog outlined the potential for increased return on investments when pharmacovigilance is implemented. The next blog in this series discusses the best ways to overcome any challenges with new systems.

Looking at a pharmacovigilance system holistically, there are interconnected, interdependent parts. Understanding how those individual parts function independently, as well as their impact on the entire system, is important. Breaking it out we have:

  1. AE/PQC intake/capturing information
  2. Storing the data and processing it (AE database)
  3. Data surveillance (analysis and understanding what the data is telling you)
  4. Reporting (regulatory as ICSRs, aggregate, and sharing information internally and externally with other stakeholders)

Subject matter experts work across or within the components. Supporting the entire system are regulatory, compliance and quality, and technology resources.

Life Sciences - How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process

This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.

Get the Guide

The chart below illustrates that while drugs were initially approved for one indication, the post-marketing surveillance of AEs helped identity secondary indications.

Pharmacovigilance

There are a host of factors that influence the value of each individual component of the pharmacovigilance system. If one is not working optimally, the system in its entirety will not work to its full potential to render the correct and useful data. As an outcome, there could be a misleading interpretation from the analysis of the pharmacovigilance data.

What can be done to minimize the old “garbage in = garbage out?” First, we must identify and overcome/mitigate the challenges that impact each component of the pharmacovigilance system. It is only then that we can move from a reactive PV system to a proactive one.

To learn more about the history of pharmacovigilance, current challenges and ROI opportunities, and how to remain proactive in the future, you can download our guide here. Or, you can submit the form below.

About the Author

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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