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Welcome to the Pharma.ai Blog, your source for expert perspectives on artificial intelligence, pharmacovigilance, drug safety, regulatory compliance, and digital transformation in the pharmaceutical industry.
Choosing a Pharmacovigilance Software Vendor: A Buyer’s Checklist
Choosing the right PV software vendor is a strategic decision. It affects patient safety, regulatory compliance, operational efficiency, and long‑term scalability. Organisations can build in-house...
The Complete Guide to AI-Powered ICSR Processing: What PV Teams Need to Know in 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...
Best Practices for AI-Assisted Signal Detection Under GVP Module IX
Each day, millions of patients rely on medicines that are already on the market. However, a medicine’s safety profile doesn’t cease once it reaches the market. Rare adverse events, long-term...
What is a drug safety database – Pharmacovigilance/Safety Database Systems explained
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...
Human-in-the-Loop AI: Why Full Automation Isn’t Always the Right Answer in PV
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...
EU Pharmacovigilance Regulation 2025/1466: Key Reforms for MAHs
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...
How is literature screening evolving in 2026 with AI and automation?
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...




