Following her attendance at DIA Europe 2024, Humaira Qureshi, President of Qinecsa Solutions, spoke with PharmaPhorum about the transforming pharmacovigilance landscape, the potential barriers and how organizations can embrace a new future-ready pharmacovigilance ecosystem.
“This offers an opportunity to embrace novel technologies, aligned with culture and processes, to demonstrate how pharmacovigilance (PV) can save time, extend resources, and transform data into actionable insights.”
What does the current PV landscape look like?
Traditionally, pharmacovigilance has been very reactive, often seen as a necessary but boring part of the pharmaceutical industry. However, today the role of PV is changing due to higher volumes of data and greater trial complexity. The drive for faster commercialisation means speed needs to be combined with high quality data.
This period of change is pushing PV to become proactive, making a shift from being a cost-absorbing function to a value-creation function. This offers an opportunity to embrace novel technologies, aligned with culture and processes, to demonstrate how PV can save time, extend resources, and transform data into actionable insights. Ultimately, this will allow us to better serve each patient by making medicines safer.
To seize the opportunities on offer, we need to take a structured approach to change. We need to benchmark our current processes and capabilities. We need to identify new capability requirements, process improvements and organisational design changes, and utilise a structured change management programme to introduce the new PV ecosystem.
What benefits does PV transformation offer?
There are several historic challenges in PV, which we can now overcome by embracing modern solutions. For example, traditionally outdated processes have required significant manual intervention and increased overall costs. By leveraging technology, we can create streamlined, cost-effective solutions to simplify processes. Technology can also help with other challenges, such as consolidating a previously dispersed geographical footprint through virtual working and centralising reporting structures using a platform approach.
Other challenges can be overcome by making better use of partnerships and collaboration. For example, outdated sourcing strategies involve low-risk activities being executed in low-cost geographies for products with an established safety profile. Development of outsourcing partner capabilities with tech-enabled processes providing strategic input will allow for fit-for-future strategy creation.
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