by Admin | Mar 22, 2026 | Explainers
EMA’s January 2026 PRAC statistics show 140 PSUR recommendations, along with reviews of risk management plans and study protocols and results. That is a useful snapshot of the scale of routine pharmacovigilance work happening in the background. For readers new to the...
by Admin | Mar 14, 2026 | Explainers
The FDA’s new Adverse Event Monitoring System (AEMS) includes a page dedicated to new safety information or potential signals of serious risks identified through postmarketing surveillance. FDA says AEMS is being implemented to consolidate multiple reporting systems...
by Admin | Mar 13, 2026 | Explainers
For pharmacovigilance professionals working in or around the European regulatory environment, PRAC safety signals are among the most important routine outputs to watch. The European Medicines Agency explains that, after each month’s Pharmacovigilance Risk Assessment...
