GREECE | Legacy NIS Circulars Face 1 October Publication Test
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CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required
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USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework GalleryUSA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework
USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework
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UK | HRA Updates Timeline for New Plan and Manage Health and Care Research Service (IRAS Replacement)
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NETHERLANDS | CCMO Introduces New Participant Information Letter for WMO Research — IVO to Become Mandatory from January 2027
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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
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CHINA | CDE Consults on RWE Communication Guideline for Expanding Paediatric Indications of Marketed Drugs
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CANADA | Panel on Research Ethics Publishes Broad Consent Guidance — Clarifying Future Use of Data and Human Biological Materials
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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 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
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