Name + title: Simone Sage, Project Manager based in Barcelona
Hire date: June 2016
Where were you born? Leverkusen, Germany
Languages spoken: German, English, Spanish, Italian and some Polish and Catalan.
What did you study at university (and where)? Bachelor’s Degree in Translation and Interpreting (Heidelberg University – Germany) and a Master’s Degree in Internationalization (University of Barcelona – Spain)
If you could learn any language, which would you pick and why? I would like to learn Portuguese, so that I can speak all languages of the Iberian Peninsula.
Do you have a bucket list? What is something you are hoping to check off the list soon? I would like to travel the word, currently I’m planning my next trip to Chile.
What are you most proud of (personally and/or professionally)? That I live and work in a foreign country.
What are your best tips for keeping projects on task? Prioritizing and no procrastinating.
What language services do we provide for regulatory affairs?
- QRD template adaptation
- Formatting following QRD convention
- Management of feedback from the Regulatory Authorities
What is a QRD template? What does it mean to be QRD compliant? Within the European Union, the product information of a medicinal product must follow the QRD template. A specific working group of the European Medicines Agency (EMA) develops, reviews and updates these templates. The templates give us the official wording that must be used for each language in summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products. The aim is to ensure consistency across different medicinal products and across all member states of the EU. The QRD template does not only define standard headings, statements and terms but also the format and layout to be used. A distinction is made between templates for the centralized procedure and templates for the Mutual Recognition Procedure (MRP)/Decentralized procedure (DCP).
What countries use the QRD template? Twenty-eight countries from the European Union use the QRD template, which requires translation into 24 official languages.
Where does translation occur in the QRD process? Once a pharmaceutical company applies for marketing authorization of a medicinal product at the EMA, the product information must be translated into all 24 official languages of the European Union. Translation ideally occurs one to two months before marketing authorization is granted as after the approval the pharmaceutical company needs to submit the final version of the translations within very short time and only small changes can be implemented. Last year we worked on several variations/updates for a veterinary product for a global pharmaceutical client. This was a very special case as we needed a team of linguists for all 24 languages who were not only familiar with the translation of QRD templates but also specialized in veterinary medicine.