NETHERLANDS | Gearing Up for the Launch of the My Research Portal in Feb 2025
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ARGENTINA | Tucuman: Revised Guidelines for Submission of Research Protocols
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ITALY | Revised Guidelines for the AIFA Observational Studies Register (RSO)
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BRAZIL | Transitioning to the New National Research Ethics System
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JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes
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EU | EMA Report on mHealth Data for Real World Evidence in Regulatory Decision-Making
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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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UK | New Toolkit to Support Cross-Border Research in the UK
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EU | EMA Reflection Paper: Use of RWD in NIS to Generate RWE
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