Tag Archives: summary of product characteristics

An introduction to MedDRA for medical translators

Posted on 15 March 2016 by Emma Goldsmith

Medical translators need to be conversant with MedDRA. Are you? Continue reading →

Posted in Medical, Regulatory, Spanish-English translation, Terminology | Tagged , , , , , , | 14 Comments

EDQM standard terms: New interface and free access

Posted on 1 December 2014 by Emma Goldsmith

A walk through the tricky EDQM Standard Terms registration process and a look at the new interface. Continue reading →

Posted in Medical, Regulatory, Spanish-English translation, Terminology | Tagged , , , , , , , | 9 Comments

MedTranslate Conference October 2014

Posted on 21 July 2014 by Emma Goldsmith

News of an international conference for medical & pharmaceutical translators this October. Continue reading →

Posted in Medical | Tagged , , , , , , | 5 Comments

Webinar: Recursos de la UE para traductores médicos

Posted on 15 July 2013 by Emma Goldsmith

Un seminario web sobre recursos médicos: EMA, EudraLex, AEMPS, términos estándar y MedDRA Continue reading →

Posted in 2. Beyond the Basics, Medical, Regulatory, SDL Trados Studio, Spanish-English translation, Terminology | Tagged , , , , , , | 4 Comments

EMA updates SmPC and package leaflet templates with new black symbol

Posted on 18 March 2013 by Emma Goldsmith

A black triangle has been added to the QRD templates for medicines subject to additional monitoring: New symbol, standard statements and translations. Continue reading →

Posted in Medical, Regulatory | Tagged , , , , | 2 Comments

How to prepare (and translate) an SmPC

Posted on 21 January 2013 by Emma Goldsmith

A new guidance section on the EMA website about how to prepare and review SmPCs. Plus, a webinar on EMA templates for translators. Continue reading →

Posted in Medical, Regulatory | Tagged , , , | Comments Off on How to prepare (and translate) an SmPC

EU languages in medical translation

Posted on 25 June 2012 by Emma Goldsmith

With the imminent deadline for electronic EMA regulatory documents, I’ve had a look at which EU languages are involved, and who translates it all. Continue reading →

Posted in Medical, Regulatory | Tagged , , , | 2 Comments

A translator’s guide to the EMA templates

Posted on 24 May 2012 by Emma Goldsmith

How to use the European Medicines Agency QRD templates to translate a Summary of Product Characteristics or Package Leaflet for a medicinal product. Continue reading →

Posted in Medical, Regulatory, Terminology | Tagged , , , , , , , | 29 Comments