JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes
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- EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs) Gallery
EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)
2024, AI, EMA, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data
EU | EMA Guidance – Harnessing AI in Medicines Regulation: Use of Large Language Models (LLMs)
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EU | EMA Reflection Paper: Use of RWD in NIS to Generate RWE
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- USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Gallery
USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
2024, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, September 2024, USA
USA | Draft FDA Guidance – Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
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UK | MHRA Data Strategy 2024 -2027
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UK | Updates to NICE RWE Framework
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USA | FDA Finalises EHR and Medical Claims Real World Data Guidance
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EU | Data Quality and Utility Label for the EHDS
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GLOBAL | CIOMS – RWD and RWE in Regulatory Decision Making
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