Workshop 1: Emma Goldsmith

EU regulatory medical writing and EMA templates: Compliance and consistency

Summary: 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.

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

Description and 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, and investigate terminology in EDQM Standard Terms, MedDRA and the WHO INN database.

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-workshop information: Attendees should bring a laptop to the workshop. A handout will be sent out in advance with files and website links that will be used on the day.


  About the facilitator

EmmaGoldsmith photo

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.

Meanwhile, in Madrid, Emma set up as a freelance Spanish to English translator, first working for local translation agencies and later – in the Internet age – specialising in medicine for global companies and individuals. She now has over 20 years’ experience translating clinical trial documentation, articles for publication in medical journals, and product information for EMA submissions. Emma is a member of Mediterranean Editors and Translators (MET) and currently serves as Webmaster on MET’s Council.

To register for this pre-conference workshop click here.