Applying AI to adverse event case processing: sharpening the impact of pharmacovigilance

For major pharma brands, for which pharmacovigilance (PV) has up to now primarily involved monitoring long-established drugs for potential side effects over time, adverse event (AE) case management has been seen first and foremost as a compliance activity. Often the value added beyond satisfying regulatory demands and managing risk has been overlooked in the face of rising workloads, a challenging economy and static budgets. The priority has been to optimise performance; make it possible to deliver more for less. Outsourcing arrangements, and use of technology, have been geared largely to enabling those improved efficiencies.

As brands diversify and add more novel and ambitious therapy areas to their portfolios, meanwhile, another driver for honed PV practices presents itself. A whole range of important new therapies and drug applications are entering the market now, supported by regulators who are working hard to shorten their paths to market without compromising patient safety.