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Medical Devices USA/Europe Regulatory…

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EUROPE 1. First references of harmonised European standards in support of Regulation (EU) 2017/745…
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ICH E6 Good Clinical Practice Principles

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The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers b…
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TGA’s Reclassification of Medic…

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The New Reclassification system for medical devices is round the corner to its effective date (25 Nov…
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Clinical Outcome Assessments (COAs) i…

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A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives …
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Serotonergic Anti-depressants for Dep…

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New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) has published few takeaways pe…
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Clinical Trial Management Guidelines …

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Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quali…
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