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Sources of Risk from Drug Products

Sources of Risk from Drug Products. Known side effects. Medication errors. Product quality defects. Unavoidable. Avoidable. Preventable adverse events. Remaining uncertainties Unexpected side effects Unstudied uses Unstudied populations. Injury or death. Modular.

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Sources of Risk from Drug Products

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  1. Sources of Risk from Drug Products Known side effects Medicationerrors Product qualitydefects Unavoidable Avoidable Preventableadverseevents • Remaininguncertainties • Unexpected side effects • Unstudied uses • Unstudied populations Injuryor death

  2. Modular Structure of Common Technical Doc u ment Module I Administrative and prescribing information (not harmonized) Module II General introduction and overall summaries of quality, n onclinical and clinical information Nonclinical Clinical written and tabulated written and tabulated summaries summaries Module III Module IV Module V Quality Nonclinical Clinical data study reports study reports

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