Reporting Side Effects

VigiFlow tips and tricks, including the rationale for coding both drug and reaction, handling dosing intervals and durations, using trade names and active ingredients effectively, leveraging the WHODrug search icon, managing multiple dosages within the same drug tab, and applying advanced search strategies such as "All Names" and "Any Names."

Terminology updates, Standardised MedDRA Query (SMQ) modifications, the reversal of medication error term classifications, new translations, and LLT currency status changes.

Off-label prescribing is a necessary and essential component of clinical practice, providing patients with access to therapies that may not otherwise be available. However, the pharmacovigilance blind spot surrounding off-label use poses a significant threat to patient safety.

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....