Oct 1, 2026
Every day, pharmacovigilance teams race against time: process thousands of adverse event reports accurately or face regulatory penalties, patient safety gaps, and reputational damage. Enter AI-powered ICSR processing. This is a paradigm shift that promises to bring...
Sep 11, 2026
Medicines can provide significant therapeutic benefits, but their use may also be associated with unintended medical events. Detecting, documenting, and evaluating these events is therefore a continuous responsibility. At the heart of this process is the drug safety...
Aug 17, 2026
As the landscape of drug safety changes, so does the pharmacovigilance market. While PV has historically been conservative due to heavy regulation, the sheer volume of safety data is driving a shift toward AI. It brings the question: do we need AI automation to the...
Jun 30, 2026
Commission Implementing Regulation (EU) 2025/1466 brought a seismic shift in regulatory expectations on February 12, 2026. This has transformed how pharmacovigilance outsourcing is governed across the European Union. It’s not just another compliance regulation; it...
Jun 18, 2026
Pharmacovigilance teams with manual literature screening find the process extremely exhausting and time-consuming. Regulatory bodies like EMA, FDA, and MHRA have noticed this and enforced regulatory standards for efficient and automated literature screening. With...
