EU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing GalleryEU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing
EU | EDPB Publishes Draft Anonymisation Guidelines — New Framework Complements Scientific-Research Guidance And Raises Expectations For RWD Sharing
Please login to view this page.
CHINA | CDE Consults on RWE Communication Guideline for Expanding Paediatric Indications of Marketed Drugs
Please login to view this page.
CANADA | Panel on Research Ethics Publishes Broad Consent Guidance — Clarifying Future Use of Data and Human Biological Materials
Please login to view this page.
UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme GalleryUK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme
UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme
Please login to view this page.
NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality GalleryNORWAY | 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
Please login to view this page.
GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data GalleryGLOBAL | 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
Please login to view this page.
EU | EMA Publishes Fourth RWE Framework Report — Darwin EU Expands Capacity as Regulator-Led RWD Studies Become More Embedded in EU Decision-Making GalleryEU | 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
Please login to view this page.
EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines
Please login to view this page.
EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle
Please login to view this page.





