Tag Archives: summary of product characteristics

An introduction to MedDRA for medical translators

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

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

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

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

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

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 , , ,

EU languages in medical translation

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