- USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
December 2023, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA
USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
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- EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024 Gallery
EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024
December 2023, EU, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update
EU | EMA Catalogues of Data Sources and Non-Interventional Studies Go Live in February 2024
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EU | Data Quality Framework for EU Medicine Regulation Finalised
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- EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation Gallery
EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation
2023, EHDS, ENCePP, EU, Members-Only, Minor Update, October 2022, RWD to Support Reg Decisions, Secondary Use of Existing Data
EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation
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EU | Launch of EMA-HMA Catalogues of Data Sources and Non-Interventional Studies in Early 2024
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EU | Mapping the Landscape of Data Intermediaries in the Context of the Data Governance Act
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LITHUANIA | Revision to the Law on Reuse of Health Data
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- GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany Gallery
GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany
2023, August 2023, Data Privacy and Data Protection, EHDS, GDPR, Germany, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
GERMANY | AKEK Statement on the Secondary Use of Patient Data for Research Purposes in Germany
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EU | HealthData@EU Landscape Analysis
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