Subject: как перевести expectedness call (из PSUR)? очень срочно! Исходник4.0 CHANGES TO REFERENCE SAFETY INFORMATION The text used as reference for the expectedness call is reported in Appendix II. No changes were made to the document during the reference period. Перевела 4.0 ИЗМЕНЕНИЯ В ПРЕДОСТАВЛЯЕМОЙ ИНФОРМАЦИИ О БЕЗОПАСНОСТИ Информация, используемая as reference for the expectedness call, приводится в Приложении II. В течение отчетного периода в документ не были внесены изменения. Что такое the expectedness call? Ожидаемое посещение? И в целом, кто - нибудь знает, где можно найти русский перевод целого PSUR для примера? |
имеются follow-up calls и expectedness calls PHARMACOVIGILANCE OFFICER (PHOF) Client: A leader company in the health sector, with international presence. With a qualified team of people and the relevant know-how is considered to be the expert in its field and an employer of choice. Τhe job holders will belong to the Regulatory Affairs Department and will be responsible for the management of pharmacovigilance affairs. More specifically, the job responsibilities will be as follows: |
"expectedness" or "labeledness" For purposes of periodic safety reporting, CCSI forms the basis for determining whether an adverse drug reaction is already LISTED or is still UNLISTED, terms which are introduced to distinguish them from the usual terminology of "expectedness" or "labeledness" which is used in association with official labeling. Thus, the local approved product information continues to be the reference document upon which labeledness/expectedness is based for the purpose of local expedited post-marketing safety reporting. |
...на русском нет ни фига... |
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