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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance

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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance2026-04-12T12:29:12+00:00

EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies

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EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies2026-04-12T12:28:08+00:00

EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation

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EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation2026-04-12T12:28:43+00:00

EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation

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EU | HTA Coordination Group Publishes 2025 Annual Report on First Year of EU HTA Regulation Implementation2026-03-10T15:30:12+00:00

EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities

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EU | ENCePP Publishes 2025 Annual Activity Report Highlighting New Working Groups and RWE Priorities2026-03-10T11:43:51+00:00

EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research

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EU | EMA Publishes New GVP Module on Pregnancy and Breastfeeding — Implications for Real-World Safety Research2026-03-10T10:09:24+00:00

EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice

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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice2026-02-16T10:11:05+00:00

EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 2026

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EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 20262026-02-16T09:57:38+00:00

EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health

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EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health2026-01-09T14:39:58+00:00

EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap

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EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap2026-01-09T14:35:29+00:00
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