NDSG Workplan 2026-2028: Data and AI in medicines regulation All news

March 23, 2026

NDSG Workplan 2026-2028: Data and AI in medicines regulation

Following the first workplan adopted in March 2025, the joint HMA/ EMA Network Data Steering…

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Discover Pharmya – Your Partner in Pharmacovigilance All news

March 18, 2026

Discover Pharmya – Your Partner in Pharmacovigilance

Ensuring drug safety and regulatory compliance is essential in today’s healthcare landscape. At Pharmya, we…

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EU implementation strategy of ICH E2D (R1) Guideline – post approval safety data: definitions and standards for management and reporting of individual case safety report All news

March 11, 2026

EU implementation strategy of ICH E2D (R1) Guideline – post approval safety data: definitions and standards for management and reporting of individual case safety report

The European Medicines Agency (EMA) has published the ICH E2D (R1) guidelines, which comes officially…

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Understanding EudraVigilance All news

March 5, 2026

Understanding EudraVigilance

💊 What is EudraVigilance?   EudraVigilance is the European pharmacovigilance database 📊. It collects and…

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A few key numbers All news

March 3, 2026

A few key numbers

Growth. Quality. Expertise. 🚀✨ Here’s a snapshot of our journey:

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Rare Disease Day All news

February 27, 2026

Rare Disease Day

Rare Disease Day – 28 February 2026 🌍 Every year on 28 February, Rare Disease…

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Final training module issued for ICH guideline E2B (R3) All news

February 24, 2026

Final training module issued for ICH guideline E2B (R3)

ICH has published Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Module…

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3 tips for understanding clinical trials All news

February 19, 2026

3 tips for understanding clinical trials

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Entry into force of new European guidelines on marketing authorization fee All news

February 17, 2026

Entry into force of new European guidelines on marketing authorization fee

These new guidelines, which enter into force on 15 January 2026, entail a change in…

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EMA and FDA set common principles for AI in medicine development All news

February 12, 2026

EMA and FDA set common principles for AI in medicine development

EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles to…

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What is the role of a pharmacovigilance service provider? All news

February 10, 2026

What is the role of a pharmacovigilance service provider?

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World Cancer Day All news

February 4, 2026

World Cancer Day

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The Key Role of the QPPV in Europe 💊🛡️ All news

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…

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Good pharmacovigilance practices All news

January 26, 2026

Good pharmacovigilance practices

The ANSM’s FAQ on Good Pharmacovigilance Practices has recently been updated. This revision introduces several…

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Pharmacovigilance in Clinical Trials 🧪💊 All news

January 6, 2026

Pharmacovigilance in Clinical Trials 🧪💊

Pharmacovigilance plays a critical role throughout the life cycle of a medicinal product, and clinical trials…

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Pharmya wish you a merry Christmas and a happy new year ! All news

December 24, 2025

Pharmya wish you a merry Christmas and a happy new year !

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025 All news

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…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 – 27 November 2025 All news

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,…

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Signal Management in Pharmacovigilance: Detection and Handling 💊🚦 All news

November 10, 2025

Signal Management in Pharmacovigilance: Detection and Handling 💊🚦

Introduction 🌍 In the pharmaceutical industry, patient safety is the top priority. Pharmacovigilance relies on…

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27 – 30 October 2025 All news

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…

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