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February 4, 2026
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The Key Role of the QPPV in Europe 💊🛡️
February 3, 2026
The Key Role of the QPPV in Europe 💊🛡️
Within the European regulatory framework, pharmacovigilance is essential to ensure patient safety. At the center…
Good pharmacovigilance practices
January 26, 2026
Good pharmacovigilance practices
The ANSM’s FAQ on Good Pharmacovigilance Practices has recently been updated. This revision introduces several…
Pharmacovigilance in Clinical Trials 🧪💊
January 6, 2026
Pharmacovigilance in Clinical Trials 🧪💊
Pharmacovigilance plays a critical role throughout the life cycle of a medicinal product, and clinical trials…
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025
December 15, 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025
Seven new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025
December 4, 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities,…
Signal Management in Pharmacovigilance: Detection and Handling 💊🚦
November 10, 2025
Signal Management in Pharmacovigilance: Detection and Handling 💊🚦
Introduction 🌍 In the pharmaceutical industry, patient safety is the top priority. Pharmacovigilance relies on…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025
November 3, 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025
Injectable tranexamic acid: serious adverse reactions when inadvertently given intrathecally PRAC agreed on a direct healthcare…
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025
September 22, 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its September 2025 meeting.…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025
September 9, 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025
EMA’s safety committee (PRAC) has started a review of medicines containing levamisole, authorised in four…
AI and Pharmacovigilance: A Duo Redefining Patient Safety 🤖💊
August 14, 2025
AI and Pharmacovigilance: A Duo Redefining Patient Safety 🤖💊
1. A global and integrated view of safety 🌐🔍 Artificial Intelligence (AI) enables the collection…
The Fundamentals of Pharmacovigilance: Why Is It Crucial for Patient Safety?
📌 Introduction Pharmacovigilance is a key medical and scientific discipline essential to public health. Its…
EMA Management Board: highlights of March 2025 meeting
March 17, 2025
EMA Management Board: highlights of March 2025 meeting
At its March meeting, EMA’s Management Board elected Rui Santos Ivo as new chair of…
ANSM’s involvement in the “Joint Actions” of the “EU for Health” program
Adopted following the Covid-19 pandemic and established by Regulation (EU) 2021/522 of 24 March 2021,…
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025
February 14, 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities,…
