Over the past few years, the amount of translations in the pharmaceutical industry has grown considerably. This has been driven by global regulatory requirements as well as new opportunities that have opened up in new markets, whether for marketing medicinal products or conducting clinical trials.
This article was written by Libor Safar and published in MultiLingual Computing magazine #121.
This article reviews some of the current issues in pharmaceutical translations related to marketing authorization and finding the optimum translation process.
The topics covered include:
- Translations for marketing authorization governed by the European Medicines Agency (EMA), and its Product Information Management (PIM) project
- Translations required during clinical trials
- Types of translation processes developed and adopted in the industry
- Different methods or levels of quality assurance (QA)
- QA process for patient reported outcomes (PROs)
- The pros and cons of back translations
- PRO measures and the linguistic validation step of cognitive debriefing (pilot testing)
To read this article, please complete this simple form below and download the full PDF version.