Category Archives: Regulatory

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

Declaration of Helsinki, October 2013, aligned in English and Spanish

The Declaration of Helsinki, October 2013: English-Spanish official versions aligned in parallel text format to import into your translation memory. Continue reading

Posted in 2. Beyond the Basics, Medical, Regulatory, SDL Trados Studio, Spanish-English translation | Tagged , , , , , , , , , , | 21 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

New IATE widget

The new IATE widget: Why translators shouldn’t use this widget to access the EU terminology database. Continue reading

Posted in Medical, Regulatory, Terminology | Tagged , , | 16 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 , , ,

MHRA Good Clinical Practice Guide

Good Clinical Practice Guide is a new book by MHRA about GCP in clinical trials. It’s a useful addition to a medical translator’s resources. Continue reading

Posted in Book reviews, Medical, Regulatory, Terminology | Tagged , , , , | 5 Comments

Track changes in SDL Trados Studio 2011 SP2: good news for medical translators

One of the new features of SDL Trados Studio 2011 SP2 is the option to show track changes in source segments. Is this going to be useful? And if so, why? Continue reading

Posted in 2. Beyond the Basics, Regulatory, SDL Trados Studio | Tagged , , , , , | 21 Comments

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

ADRs: a new EMA website and a terminology review

News of public access to the EudraVigilance suspected adverse drug reaction (ADR) reports database. Plus, a translator’s review of ADR terminology. Continue reading

Posted in Medical, Regulatory, Terminology | Tagged , , , | 7 Comments