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PRAC recommendations on signals adopted at the  6-9 July 2026 PRAC meeting

August 11, 2026

Product information updates for desogestrel/etonogestrel and meningioma, levonorgestrel intrauterine systems and ectopic pregnancy, and information concerning atogepant and insomnia, CGRP antagonists and Raynaud's phenomenon, oseltamivir safety in critically ill patients, sacituzumab govitecan and interstitial lung disease, selpercatinib and intestinal lymphangiectasia, and sevoflurane and acute encephalopathy in patients carrying the mitochondrial DNA variant m.11232T>C.

The Digital Revolution in Pharmacovigilance

August 4, 2026

The digital revolution—encompassing AI, machine learning, big data analytics, EHRs, mobile applications, and social media monitoring—is reshaping how ADRs are detected, assessed, and prevented.

Essential Tools for Effective Root Cause Analysis in Healthcare

July 27, 2026

This essay provides a comprehensive examination of RCA methodologies within, exploring the application of Six Sigma and DMAIC frameworks, the A3 problem-solving approach, and the essential analytical tools including Pareto diagrams, the Five Whys technique, and fishbone (Ishikawa) diagrams.

New product information wording – Extracts from PRAC – June 2026

July 21, 2026

Angioedema with darolutamide, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome with gemcitabine, neurodevelopmental disorders with paternal valproate exposure, fixed drug eruption with iodinated X-ray contrast agents, and protein-losing gastroenteropathy with zolbetuximab.

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