☀️ Summer brings higher temperatures—but pharmacovigilance never takes a holiday All news

July 9, 2026

☀️ Summer brings higher temperatures—but pharmacovigilance never takes a holiday

Heat exposure can affect the stability of certain medicinal products, potentially impacting their quality, efficacy,…

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EMA publishes PRAC recommendations on safety signals All news

July 7, 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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CTIS sponsor handbook updated All news

July 2, 2026

CTIS sponsor handbook updated

The European Medicines Agency (EMA) has released version 6.3 of the Clinical Trials Information System…

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EMA publishes 2025 AI Observatory report All news

July 1, 2026

EMA publishes 2025 AI Observatory report

The European Medicines Agency (EMA)’s 2025 AI Observatory report highlights developments in guidance and policy,…

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🔎 Why report an adverse drug reaction even if it is already known? All news

June 25, 2026

🔎 Why report an adverse drug reaction even if it is already known?

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Pharmacovigilance works when collaboration works All news

June 23, 2026

Pharmacovigilance works when collaboration works

💊 Pharmacovigilance works when collaboration works 🤝 No safety without cooperation. 🌍 Safer medicines are…

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The EMA releases Annual Report 2025 All news

June 18, 2026

The EMA releases Annual Report 2025

The European Medicines Agency (EMA) has released its Annual Report 2025, highlighting key initiatives and…

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🔎 What is a pharmacovigilance signal? All news

June 16, 2026

🔎 What is a pharmacovigilance signal?

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The EMA releases Q&A on the use of real-world data All news

June 11, 2026

The EMA releases Q&A on the use of real-world data

The European Medicines Agency (EMA) has published a Questions and Answers document aimed at clarifying…

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Where Do PV Signals Come From? All news

June 9, 2026

Where Do PV Signals Come From?

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Is Pharmacovigilance Mandatory ? Understanding Regulatory Obligations for Pharmaceutical Companies and Service Providers All news

June 4, 2026

Is Pharmacovigilance Mandatory ? Understanding Regulatory Obligations for Pharmaceutical Companies and Service Providers

💊 Patient safety is a fundamental priority throughout a medicinal product's lifecycle. This is why…

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Monitoring the European clinical trials environment All news

June 2, 2026

Monitoring the European clinical trials environment

The Accelerating Clinical Trials in the EU (ACT EU) initiative has published a report “Monitoring…

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Trust and transparency All news

May 29, 2026

Trust and transparency

🔬 In pharmacovigilance, trust is more than a value — it is the foundation of…

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026 All news

May 26, 2026

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.

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International Clinical Trials Day All news

May 20, 2026

International Clinical Trials Day

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EMA meets pharmaceutical leaders to discuss the future direction of the EU pharmaceutical system All news

May 19, 2026

EMA meets pharmaceutical leaders to discuss the future direction of the EU pharmaceutical system

The European Medicines Agency (EMA), together with Heads of Medicines Agencies (HMA), met senior executives…

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FAQ updated for the CTIS training programme All news

May 15, 2026

FAQ updated for the CTIS training programme

The European Medicines Agency (EMA) has published an updated FAQ for the Clinical Trials Information…

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👩‍⚕️ International Nurses Day All news

May 12, 2026

👩‍⚕️ International Nurses Day

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CMDh publishes Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs All news

May 7, 2026

CMDh publishes Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs

Occasionally, it may not be possible to finalise an issue (e.g. a signal or a…

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What if how you feel after taking a medication really mattered? All news

May 5, 2026

What if how you feel after taking a medication really mattered?

After taking a medication, you may notice something unusual: extreme tiredness, headaches, rashes, nausea… 👉…

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