Approaches and benefits to moving from operational to scientifically-driven pharmacovigilance
With industry focus on patient-centric care, biopharmas are challenged on how to allocate more resources to the science of signal detection, epidemiology, and risk management. Learn how advancements in modern technologies drive operational efficiency and streamlines safety science.
Pharmacovigilance Transformation in People and Organization
It is important to shift the focus of pharmacovigilance from one that is seen as a burden, toward one that attracts people that are geared toward a more scientific mindset. How do you make PV more attractive? By highlighting the potential impact on patients, and the potential value it can add to life sciences. New roles can be introduced, such as data scientist positions, that specifically utilize new and efficient technologies to improve processes and interest a younger workforce.
Pharmacovigilance Transformation in Process
Traditionally, the processes around pharmacovigilance are fragmented, siloed, and rife with manual tasks and workflows. By introducing modern, unified cloud technologies, pharmacovigilance can begin to break down application and data silos, moving toward simplification of workflows through automation and AI.
Defining Value within Pharmacovigilance
Quantifying pharmacovigilance has been a challenge for years, but can be accomplished by taking steps in the right direction. Estimating the financial cost of a product recall, and providing tangible evidence for your leadership team can have a massive impact. While the impact on brand awareness and customer loyalty of a product recall is more difficult to estimate, providing both the financial and brand impact can deliver a more holistic story. Data studies can also show how much sooner a signal can be detected using new data sources, methods and technologies versus the traditional ways of performing signal analysis, highlighting the positive financial effect of PV transformation.
Collaboration Between Health Authorities and Organizations
The complex regulatory global environment we all work in can make it challenging to maintain an inspection-ready pharmacovigilance environment. Through industry transparency and collaboration between pharma and health authorities, we can focus regulation changes into win-win scenarios. Global strategy can also help drive alignment to meet global regulations.
Pharmacovigilance Transformation in Technology and Data
There are many instances of duplication of data in the pharmacovigilance landscape. The legacy applications being used are siloed, bulky, and difficult to update and keep up with a changing landscape. By adopting single-source applications to view all data and content, organizations can streamline and remove repetitive and manual processes. Cloud technologies also offer solutions that are easy to improve, and update on a constant, seamless cycle.
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