Subject: Medical Complaint, Technical Complaint gen. Мой вар.:Medical Complaint – претензия медицинского характера Technical Complaint –претензия технического характера (претензия по качеству) Контекст: Medical Complaint: A report of an adverse event (see AE definition) associated with the use of xxx product. Medical complaints are handled by DSP. A technical investigation may be required in addition to the medical investigation, if requested by DSP. Technical Complaint: A complaint involving the physical, chemical or microbiological quality and/or labeling or packaging of marketed products, including, but not limited to: appearance, taste, odor, broken tablets, low fills, foreign materials, foreign product or defective packaging The purpose of this Standard Operating Procedure (SOP) is to describe the requirements for handling of all spontaneously reported medical complaints received by Drug Safety & Pharmacovigilance (DSP) which may have a technical component, and reports with technical complaints received by Quality Assurance (QA) which may be associated with a medical component (potential adverse event (AE) or lack of effect (LOE)). Еще вопрос: как лучше перевести здесь medical component, technical component, technical investigation, medical investigation. |
фактор? фактор мед. /технич. характера |
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link 22.05.2012 9:07 |
component - составляющая investigation - исследование |
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