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EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data

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EU | EMA Adds New RWD Q&A — Reinforcing ICH M14 Expectations for Non-Interventional Studies Using Real-World Data2026-06-12T10:16:59+00:00

EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space

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EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space2026-05-14T14:09:14+00:00

EU | EDPB Publishes Draft Guidelines on Processing Personal Data for Scientific Research — Clarifying GDPR Expectations for Research and Real-World Evidence

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EU | EDPB Publishes Draft Guidelines on Processing Personal Data for Scientific Research — Clarifying GDPR Expectations for Research and Real-World Evidence2026-05-14T13:26:11+00:00

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
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