E-C Translation Of Pharmacovigilance Guideline From The Perspective Of Skopos Theory

Translation is an important means of intercultural communication playing a great role in the international cooperation and resource pooling.In recent years,the national drug regulatory authority(RA)has been leading the whole pharmaceutical industry to improve the industry standards of drug development,manufacture and pharmacovigilance(PV).International PV guidelines are gradually introduced to China.At present,some relevant translation works including those published by national RA are available.However more translation works of high quality are expected by pharmaceutical and medical practitioners.Translation of industry guidelines requires high accuracy and logicality for which translators need to analyze the characteristics of source language and master background knowledge.This report aims to summarize the language features of PV guidelines and explore the application of functionalist Skopos theory in translating such type of scientific texts based on the task of E-C translation of Guideline on good pharmacovigilance practices(GVP)Module V so as to promote the spread of PV knowledge.This translation practice report consists of five parts.The first part introduces the background,content and significance of the translation task.The second part elaborates on the preparation of translation practice,the difficulties and solutions in the translation process,and the revision methods.The third part sketches the functionalist Skopos theory.The fourth part is the analysis of practical cases.The fifth part summarizes the findings gained from the task and the limitations of the report.