EMA releases ICH E6 (R3) Guideline for Good Clinical Practice Step 5 All news

July 21, 2026

EMA releases ICH E6 (R3) Guideline for Good Clinical Practice Step 5

The European Medicines Agency (EMA) has published the consolidated version of ICH E6 (R3) Guideline…

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Tailored Pharmacovigilance Services for Your Needs All news

July 16, 2026

Tailored Pharmacovigilance Services for Your Needs

Every organisation has unique challenges. At Pharmya, we deliver flexible and tailored pharmacovigilance solutions to…

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Meeting highlights from the PRAC: 6-9 July 2026 All news

July 15, 2026

Meeting highlights from the PRAC: 6-9 July 2026

The PRAC (Pharmacovigilance Risk Assessment Committee) agreed on Direct Healthcare Professional Communications (DHPCs) for the…

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☀️ 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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