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Informed Consent for Non-English Speakers: Tips for Translation Success
Recruiting of non-English speakers for U.S.-based and global clinical trials is on the rise. As a result of this, foreign language translation becomes a critical component of clinical trials management. If done right, translations can play an important role in meeting global product demands. Otherwise, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits…
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Tips for Translation and Regulatory Compliance in the Pharmaceutical and Medical Device Industries
If you pick up a bottle of one of your prescription medicines you'll see various types of information on it - dosage and frequency of use, storage instructions, side effects, warnings, etc. – often in more than one language. The distribution of drugs and devices across borders has done away with translating packaging and labels as a luxury or value-add and, instead, made it a highly regulated, and more often than not, required process…
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Ever-Changing English: A Translator’s Headache
Aside from the obvious vocabulary changes due to the emergence of an extraordinary array of new objects and processes, whether in daily life (satellite TV in remote parts of China) or highly specialized situations (biotechnology bots of various sorts), English is undergoing changes in usage that I believe are the true headache for a translator…
English Portuguese

Back Translation for Quality Control of Informed Consent Forms
FDA regulations and ICH guidelines both require that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative." Obviously, if an Informed Consent Form (ICF) is written in a language that the subject does not understand, it must be translated into a language the subject does understand…
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Difficulties in Translating Medical Texts
“Durante o round, o staff prescreveu um dripping de insulina e ordenou um check up duas horas depois.” That is how it is said in Portuguese! Or at least that is the best way to make it understood in the medical environment. This is where the difficulties in translating medical texts begin: the use of terms in foreign languages — especially English — is so common that if we wanted to substitute round for its Portuguese equivalent “ronda,” staff for “chefe de equipe” and dripping for “gotejamento,” we would force the doctor-reader to “untranslate” a fair part of the text to be able to understand it. On the other hand, keeping these terms in their original language may render the text unintelligible to the layman, to students who are starting their course, or anybody else who has little knowledge of the foreign language. So, what to do?…
English Portuguese

Multilanguage Electronic Labelling for Medical Device Companies
Second only to the U.S, the European medical device market represents an annual sales volume in excess of 40 Billion Euros and is increasing. With the addition of new countries to the European Union (EU), the life-sciences industry is poised to be extremely successful in coming years. However, that growth does not come without complexities…
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The Challenge of Translating Chinese Medicine
Q. How does one get into something as recherché and specialized as translating Chinese medical texts?
A. I suppose it's what our colleague in Mexico City recently called El Demonio de Traducción. While in England, I had done some play translations for the RSC and became fascinated with the overall problem of putting across one culture in terms of another without sacrificing either one's value system. Just because a line was funny in German or French didn't guarantee it would be in English—a lot of other factors were at work: phonetics and usage of course, but also the totality of values shared by a culture. I started looking for other outcroppings of similar linguistic problems and collided with medicine …

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Características del discurso biomédico y su estructura: el caso de las Cartas al director
In this paper we provide a proposal for the analysis of the rhetorical structures of twenty-five texts in Spanish. These texts, chosen at random, are representative of written discourse in the field of biomedicine, and belong to the subgenre of opinion: the Carta al director. The aim is, consequently, to check if the same schema is found in each text. Within this study the rhetorical structures of the selected texts are analyzed by applying a modified analysis of scientific texts set forth by the linguist Paltridge (1997), based on keys and influenced by the Genre Analysis Theory (Swales, 1990). In the method proposed at least one key is used to represent each sentence of the selected texts so that structural content in the corpus can be clearly identified. (The article is in Spanish)…
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Translating SOPs in a Pharmaceutical Manufacturing Environment
These are comments on the general practice of translation and specific issues I have found in translating Standard Operating Procedures, SOPs, in a pharmaceutical manufacturing environment, which I offered at the ATA Seminar on Translation in the Pharmaceutical Industry held on January 24 in San Juan, Puerto Rico. The materials were gathered by Josй Rodriguez, Gloria Colуn, and others who work with us at a pharmaceutical facility in Juncos, Puerto Rico. While sorting through the records our work team has kept of issues we have encountered, mostly in SOPs, but many in other controlled documents, such as documented practices, and non-controlled documents, such as letters from government agencies or press releases, we tried to cull what we feel are interesting examples that may be helpful to others…
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Immunology—A Brief Overview, Part 1, Part2 & Part3
This series of articles comes with an English-Brazilian Portuguese downloadable glossary of terms used in immunology with the English terms explained (in English) and translated into Portuguese. You can download it now…
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