Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC), 26-29 October 2026 All news

November 10, 2026

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC), 26-29 October 2026

The European Medicines Agency (EMA) has published the meeting highlights from the PRAC meeting held…

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Quality is a continuous commitment All news

October 29, 2026

Quality is a continuous commitment

📋 Quality in pharmacovigilance goes beyond procedures. Training, documentation, periodic review and continuous improvement all…

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Minutes from Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 31 Aug to 03 Sep 2026 All news

October 27, 2026

Minutes from Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 31 Aug to 03 Sep 2026

The European Medicines Agency (EMA) has published the minutes of the PRAC meeting held from…

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Outsourced pharmacovigilance: reliable support All news

October 22, 2026

Outsourced pharmacovigilance: reliable support

🤝 Managing pharmacovigilance obligations requires reliable processes and specialist expertise. Outsourcing selected activities can help…

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Meeting highlights from Committee for medicinal products for human use (CHMP) meeting held on 12-15 Oct 2026 All news

October 20, 2026

Meeting highlights from Committee for medicinal products for human use (CHMP) meeting held on 12-15 Oct 2026

The European Medicines Agency (EMA) has published the meeting highlights from the CHMP meeting held…

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Scientific literature monitoring All news

October 15, 2026

Scientific literature monitoring

📚 Scientific literature can provide valuable information on suspected adverse reactions and emerging safety concerns.…

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EMA updates the Rules of Procedure for PRAC All news

October 13, 2026

EMA updates the Rules of Procedure for PRAC

The European Medicines Agency (EMA) has published an updated version of the Rules of Procedure…

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EMA publishes PRAC recommendations on safety signals All news

October 6, 2026

EMA publishes PRAC recommendations on safety signals

The European Medicines Agency (EMA) has published an overview of the recommendations adopted by the…

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🎀 Pink October: Let’s take action for women’s health All news

October 1, 2026

🎀 Pink October: Let’s take action for women’s health

As part of Pink October, Breast Cancer Awareness Month, we would like to highlight the…

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CTIS Sponsor Guidance: New Safety Module for the Annual Safety Report All news

September 29, 2026

CTIS Sponsor Guidance: New Safety Module for the Annual Safety Report

The European Medicines Agency (EMA) has released new user guidance on the New Safety Module…

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📋 In pharmacovigilance, the quality of safety information matters All news

September 25, 2026

📋 In pharmacovigilance, the quality of safety information matters

Complete, accurate and timely documentation supports robust case assessment, effective safety monitoring and regulatory compliance.…

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Meeting highlights from Committee for medicinal products for human use (CHMP) meeting held on 14-17 Sep 2026 All news

September 22, 2026

Meeting highlights from Committee for medicinal products for human use (CHMP) meeting held on 14-17 Sep 2026

The European Medicines Agency (EMA) has published the meeting highlights from the CHMP meeting held…

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🌍 Today is World Patient Safety Day All news

September 17, 2026

🌍 Today is World Patient Safety Day

In pharmacovigilance every safety report, signal assessment and risk-minimisation action contributes to a common objective:…

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The EMA releases Guideline on good pharmacovigilance practices, Module III – Pharmacovigilance inspections (Rev. 2) All news

September 15, 2026

The EMA releases Guideline on good pharmacovigilance practices, Module III – Pharmacovigilance inspections (Rev. 2)

The European Medicines Agency (EMA) has published the Guideline on good pharmacovigilance practices (GVP), Module…

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🚨 Not every safety signal means there is a new risk All news

September 10, 2026

🚨 Not every safety signal means there is a new risk

In pharmacovigilance, a safety signal is information that suggests a possible new association between a…

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Minutes from Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 08 to 11 June 2026 All news

September 8, 2026

Minutes from Pharmacovigilance Risk Assessment Committee (PRAC) meeting held on 08 to 11 June 2026

The European Medicines Agency (EMA) has published the minutes of the PRAC meeting held from…

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5 common pharmacovigilance inspection findings All news

September 3, 2026

5 common pharmacovigilance inspection findings

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Minutes from Committee for medicinal products for human use (CHMP) meeting held on 23-26 Feb 2026 All news

September 1, 2026

Minutes from Committee for medicinal products for human use (CHMP) meeting held on 23-26 Feb 2026

The European Medicines Agency (EMA) has published the minutes of the CHMP meeting held from…

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🔎 From signal to action: the pharmacovigilance lifecycle All news

August 27, 2026

🔎 From signal to action: the pharmacovigilance lifecycle

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EMA publishes information about their medical literature monitoring All news

August 26, 2026

EMA publishes information about their medical literature monitoring

The European Medicines Agency (EMA) is monitoring selected medical literature for reports of suspected adverse…

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