ePrivacy and GPDR Cookie Consent by Cookie Consent

Our Blog

pharma.AI NEWS

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.

AI assisted signal detection GVP Module IX

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 effects, and unexpected drug interactions may only emerge after widespread use, making continuous safety monitoring essential. The challenge of the pharmacovigilance market isn’t the lack of data. It’s the...
READ MORE ABOUT THIS HERE

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 continuous responsibility. At the heart of this process is the drug safety database. It’s a structured repository for collecting, managing, assessing, and reporting adverse events and adverse drug...
READ MORE ABOUT THIS HERE

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 toward AI. It brings the question: do we need AI automation to the extent we think we do? Is the adoption of AI actually going to replace scientific judgment with algorithmic probability? Or will AI...
READ MORE ABOUT THIS HERE

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 the European Union. It’s not just another compliance regulation; it has reshaped vendor management, data privacy and operational transparency. This solidifies the oversight of outsourced PV...
READ MORE ABOUT THIS HERE

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 standards for efficient and automated literature screening. With these bodies pressing MAHs (Marketing Authorization Holders), literature screening has become a critical compliance frontier where...
READ MORE ABOUT THIS HERE

New Posts