NORWAY | Artificial Intelligence and Research Ethics
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GLOBAL | ICH E6 R3 Annex 2…Additional Considerations for Interventional Clinical Trials
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GERMANY | Medicines Act (AMG) Revised by the Newly Implemented medical Research Act (MFG)
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GERMANY | Medical Research Act (MFG) Implemented
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EU | Implementation of the Health Technology Assessment Regulation
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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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- 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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