EMA templates and EU terminology for medical translators – the Basics
There are strict requirements in Europe for translating Summaries of Product Characteristics, Package Leaflets and Labelling (all the documents that make up medicinal product information). To comply with these requirements, you are expected to use specific templates, standard terms and controlled terminology.
You may already be translating these documents and wondering whether you’re doing it right, or you may want to start working in this field and you’re not sure how to go about it.
At this webinar you’ll learn to find your way around:
- the product information itself – Summary of Product Characteristics, Package Leaflet and Labelling
- some essential abbreviations – QRD, EDQM, SmPC, EUTCT
- the EMA templates and appendices for translating product information
- free online terminology resources that are mandatory in this field
This video is followed by a second, more in-depth part on the practical aspects of EMA templates, available here.
Emma, MITI, DipTrans, originally trained as a registered general nurse at St Thomas’ Hospital in London. She moved to Spain in 1987 and for the following ten years she worked as a staff nurse through the BNA (British Nursing Agency) during visits to England. This gave her broad experience in a wide range of hospital settings.
After studying translation in Madrid, she set up as a freelance Spanish to English translator, specialising in medicine. Emma now has over 20 years’ experience translating clinical trial documentation, research articles and product information for EMA submissions. She shares her knowledge with other translators through her blog, Signs & Symptoms of Translation.
1 hour 4 min
Who should watch it?
Translators who work with European languages and have limited or no experience with EMA templates.
What are the benefits to you?
This video will give you the theoretical grounding you need to translate medicinal product information. You’ll come away feeling more confident about EU regulatory medical writing in general and EMA templates in particular.