- NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality Gallery
NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality
NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality
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- GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data Gallery
GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data
GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data
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- EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making Gallery
EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making
EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making
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EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines
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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle
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- UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices Gallery
UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices
2026, June 2026, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK
UK | MHRA and NICE Continue Real-World Evidence Scientific Dialogue Programme — Expanding Early RWE Discussion to Medical Devices
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- NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation Gallery
NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation
NORWAY | Government Consults on New European Health Data Space Act — National Implementation of EHDS Would Restructure Access to Health Data for Care, Research and Innovation
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- GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research Gallery
GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research
GREECE | National Biomedical Research Registry Delivered to IDIKA — New Digital Infrastructure Expected to Strengthen Oversight of Clinical and Biomedical Research
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FRANCE | CNIL Updates MR-003 for Health Research Without Consent — New Requirements for RIPH-3 and Prospective Non-Interventional Studies
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