Reporting Side Effects

To separate signal from noise, the Uppsala Monitoring Centre (UMC) developed VigiGrade—a tool that assigns a completeness score to every single ICSR.

Most pharmacovigilance (PV) teams obsess over the seven-day and fifteen-day reporting deadlines, yet they overlook a far more insidious window—the first 48 hours after safety information reaches the company. This is the triage gap: a seemingly administrative interlude during which the clock-start date (Day 0) for expedited Individual Case Safety Reports (ICSRs) is...

Comprehensive analysis of the MedDRA Version 29.0 IME list, including newly added terms, demoted terms, primary SOC changes, and the clinical significance of key updates. A comparative analysis with Version 28.1 highlights the evolution of this essential regulatory tool.

This article provides a detailed medical and scientific overview of VigiBase, based on the 2026 resource profile update published by UMC researchers. It covers the database’s history, data collection and processing workflows, coding standards (WHODrug Global and MedDRA), analytical tools (including vigiMatch, vigiGrade, vigiRank, and the VigiBase pregnancy algorithm), and key descriptive statistics....

Artificial intelligence (AI) is transforming pharmacovigilance. From automated case processing to signal detection and duplicate identification, AI systems promise to enhance efficiency, improve quality, and enable entirely new capabilities. However, the rapid proliferation of AI tools—coupled with decreasing development costs—creates a critical challenge: how do we know which AI systems actually work?

With over 6,000 identified rare diseases and millions of medical devices in daily use worldwide, standardized adverse event reporting is critical for public health safety.

Version 29.0, released in March 2026, introduces significant terminology updates, including new terms, revised hierarchies, changes to Standardised MedDRA Queries (SMQs), and important modifications to medication error concepts.