About stuart.mccully
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EU | EMA (and FDA) Publish Guiding Principles on Good AI Practice in Drug Development
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CANADA | New Canada’s Drug Agency Resource Explains National Drug Pathway, Highlighting Real-World Data RoleÂ
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VIETNAM | New Data Protection Law and Decree Set Out Stringent Rules with Real-World Research Implications
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UK | HRA Overhauls Non-CTIMP Terminology, Modification Processes and Transparency Requirements — Implementation from 28 April 2026
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EU | ICH M14 Guideline on Non-Interventional Studies Using RWD Becomes Legally Effective — Implications for EU Pharmacovigilance Practice
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EU | Updates to Regulation (EU) No 520/2012 — Key Pharmacovigilance Changes Applicable from 12 February 2026
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UK | MHRA Seeks Input on Regulation of AI in Healthcare at ‘Pivotal Moment’
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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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