Category Archives: Regulatory

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

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

Posted on 14 January 2014 by Emma Goldsmith

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

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

New IATE widget

Posted on 8 April 2013 by Emma Goldsmith

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

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

MHRA Good Clinical Practice Guide

Posted on 3 October 2012 by Emma Goldsmith

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

Posted on 3 August 2012 by Emma Goldsmith

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

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

ADRs: a new EMA website and a terminology review

Posted on 1 June 2012 by Emma Goldsmith

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