The Linguist

The Linguist 56,4 – August/September 2017

The Linguist is a languages magazine for professional linguists, translators, interpreters, language professionals, language teachers, trainers, students and academics with articles on translation, interpreting, business, government, technology

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16 The Linguist Vol/56 No/4 2017 FEATURES Pavla Dohnalová, translator for the pharmaceutical industry, looks at the potential pitfalls for work that carries a health risk S hortly after I launched my career as a professional translator, one of the agencies I worked with began sending me documents to translate connected with the development of a new drug. That was my first encounter with the field of medical and pharmaceutical translation, which became one of my main specialisms – specifically regulatory affairs and clinical trials documentation. Beyond an A level in chemistry, I have no formal qualifications in this area and quickly realised that, if I wanted to succeed as a medical translator, I would have to bridge the knowledge gap. I began attending webinars, online courses, talks and lectures dealing with the subject. This is (and must be) a continuing process, as knowledge in medicine and connected legislation is constantly changing. The regulatory affairs function of the medical and pharmaceutical industry aims to ensure that every new medicine is as safe and effective as possible. A vast amount of documentation is produced in clinical trials (where the development of new drugs begins), and throughout the whole manufacturing process, because the medicine is constantly being monitored. All these documents, including labelling and packaging, have to be kept up-to-date, as have the texts which are marketing the product. Patient safety is the most important concern here. In the EU, each member state has its own legislation, which is closely linked to European Medicines Agency (EMA) regulations. The EMA, national regulatory authorities of the EEA countries and the European Commission form the European medicines regulatory network. To consolidate all the necessary documentation, the EMA publishes quality review of documents (QRD) templates for all regulatory affairs texts. These continuously updated templates are available on the EMA website in the languages of EU member states and Norwegian, and include annexes (i.e. texts of summary of product characteristics or SPC, labelling and patient information leaflet or PIL, among others), appendices, guidelines and various terminology. Another important database published by the European Directorate for the Quality of Medicines and Healthcare (EDQM) contains terminology, covering terms for routes of administration, containers and pharmaceutical dosage forms (specialist terms are available in 33 languages, including Turkish and Kazakh). The use of QRD templates and EDQM standard terms is mandatory in all regulatory affairs and clinical trials documentation, as is the clinically-validated standardised medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), which is available in 11 languages, including Chinese and Japanese. A wealth of information is available on the EU Clinical Trials Register, including the latest updates on current clinical trials. As an English to Czech translator, I use the website of the Czech regulatory body (SÚKL; Státní ústav pro kontrolu lé čiv) for country-specific issues. Take nothing for granted The translated terminology and templates make some things easier, but they by no means remove all the potential obstacles and problems. One still has to look at the text with a critical eye and an open mind, because things that seem unambiguous can prove to be very hard nuts to crack. Abbreviations, for example, have to be understood in the context of the particular text. 'SAE' is a commonly used abbreviation for 'serious adverse event' (describing a bad reaction to the administered drug), but when I found this abbreviation in the 'Statistical methods' part of a protocol summary, it was clear that there was another meaning: Summary statistics will be provided for all study variables with descriptive statistics (number of observations, mean, standard deviation, median, minimum, maximum and from the analysis model the least squares means, SAE's and confidence limits) for numerical (or continuous) variables and with frequency and percentage for categorical variables. After some research, I was able to clarify with the client that SAEs in this context meant 'small area estimation', a statistical technique involving the estimation of parameters for small sub-populations. It is good practice to verify potentially problematic terms and phrases with the client in this way, not least because quite a few English texts are now written by non-native speakers, which can have an impact on the text. Recently there has been an increase in the number of new medical products that pharmaceutical companies are evaluating in clinical trials, with a view to registering them for the market in other countries. In some cases, the substances which are the basis for the new drug do not yet have target-language Prescriptive work Fierce discussions between the regulatory authority representative and translator can follow

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