GLOBAL | ICH Concept Paper Endorsed for RWE Guideline on Medicines Effectiveness (ICH E23)
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EU | European Commission Proposes Health Innovation Package to Strengthen Biotech, Medical Devices and Cardiovascular Health
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EU | EMA and HMA Highlight Role of Alzheimer’s Disease Patient Registries in Addressing Evidence Gap
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UK | MHRA Signals Major Change for Rare Disease Treatments
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- EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research Gallery
EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
2025, AI, Cvbersecurity, Data Privacy and Data Protection, EHDS, EU, Expert Insights, Members-Only, Minor Update, October 2025
EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
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UK | MHRA Selects Next-Phase AI Tools with Potential to Detect Diseases Earlier
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EU | TEHDAS2 Opens Public Consultation on Health Data Access Guidelines — Paving the Way for EHDS Implementation
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EU | European Medicines Agencies Network Data Strategy Prioritises Real-World Data Integration
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CANADA | Health Canada Update Guidance on Expanded Access Clinical Trials
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