Category Archives: Regulatory

New information for excipients in package leaflets

Posted on 13 October 2017 by Emma Goldsmith

New safety warnings in medicine package leaflets published in all EU languages, Icelandic and Norwegian. Continue reading →

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

Legalese in medical translation: a problem paragraph solved

Posted on 30 June 2017 by Emma Goldsmith

How to tackle a legal paragraph in a medical text? Ask a colleague! Continue reading →

Posted in Medical, Regulatory, Spanish-English translation | Tagged , , , , | 5 Comments

AEMPS, CEIm and REec: 3 terms in Spanish Royal Decree 1090/2015

Posted on 11 April 2017 by Emma Goldsmith

The unofficial English translation of the Royal Decree on the AEMPS website: thoughts on 3 terms and a tmx version of the alignment Continue reading →

Posted in Medical, Regulatory, Spanish-English translation | Tagged , , , | 4 Comments

Two webinar videos on EMA templates

Posted on 7 September 2016 by Emma Goldsmith

News of two September webinars for medical translators. Continue reading →

Posted in Medical, Regulatory | Tagged , , , , , | 17 Comments

Brexit, Clinical Trials and Medical Translators

Posted on 27 June 2016 by Emma Goldsmith

Changes in clinical trial regulations in post-Brexit UK. How will medical translators be affected? Continue reading →

Posted in Medical, Regulatory, Spanish-English translation | Tagged , , , , , , | 13 Comments

MedDRA: new version 19.0

Posted on 23 March 2016 by Emma Goldsmith

News of the March 2016 update to the MedDRA terminology databases Continue reading →

Posted in Medical, Regulatory, Spanish-English translation, Terminology | Tagged , , , , , , , | 2 Comments

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

How to align any EU legislation in any two EU languages

Posted on 15 January 2016 by Emma Goldsmith

A description of two methods to align the new Clinical Trials Regulation (or any other EU legislation) Continue reading →

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

New terminology for a new regulation

Posted on 16 December 2015 by Emma Goldsmith

Are you conversant with the new definitions in the EU Clinical Trials regulation? Continue reading →

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

New clinical trials regulation for Europe

Posted on 27 November 2015 by Emma Goldsmith

What changes will the new EU Clinical Trials Regulation bring? What are the implications for translators? Continue reading →

Posted in Medical, Regulatory | Tagged , , , , | 12 Comments