MET workshops

EMA templates and EU terminology

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.

Facilitator: Emma Goldsmith

Purpose: To familiarise translators with the European Medicines Agency (EMA) templates, comply with terminology requirements and use translation technology to ensure consistency.

Description/structure: First, we will look at the documents that make up product information and guidelines. Then, we will download and work on the EMA templates and appendices, focusing on practical aspects of the translation workflow and discussing the pros and cons of converting these documents into term bases and translation memories. We will also look at language register, comparing the different styles of the Summary of Product Characteristics and Package Leaflet. After a break, we will align a template in your source and target language, investigate a bilingual corpus from OPUS and search for terms in MedDRA and the WHO INN database. Finally, we will find solutions for translating terms that don’t appear in the EDQM Standard Terms.

Who should attend? Translators who work with European languages and want to learn about or refresh their knowledge of EU regulatory medical writing in general and EMA templates in particular.

Outcome skills: By the end of the workshop, attendees will feel more confident about complying with the strict requirements for translating EU product information and they will come away with a better understanding of how to manage the technological aspects of this field.

Pre-meeting information: If possible, attendees should bring a laptop to the workshop. Before the workshop, attendees will be sent a hand-out with website links and programs that will be used on the day.

About the facilitator: Emma Goldsmith originally trained as a registered general nurse at St Thomas’ Hospital in London. She moved to Spain in 1987 and for the following 10 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, including intensive care, A&E, general surgery, geriatrics, obstetrics and gynaecology, and paediatrics.
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 protocols, informed consent forms, articles for publication in medical journals, clinical practice guidelines, adverse drug reaction reports and product information for EMA submissions.

What participants have said about this workshop: 
“Excellent workshop. Lots of useful information and practical tips.”
“Lots of information and resources, nicely packaged.”
“[Emma is] a true professional with a lot of experience in this area.”