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Emma Goldsmith
Spanish to English medical translator
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Archives
Category Archives: Regulatory
An on-site inspection
I’ve just spent a week interpreting and sight translating for a clinical trial inspection at a hospital in Madrid. While I can’t share many of the details, here’s an anonymised review of the week and how I prepared for the … Continue reading
Posted in Medical, Regulatory, Spanish-English translation, Terminology
Tagged audit, clinical trial, FDA, INSPECTION
4 Comments
New information for excipients in package leaflets
New safety warnings in medicine package leaflets published in all EU languages, Icelandic and Norwegian. Continue reading
Posted in Medical, Regulatory
Tagged adverse reactions, EMA, excipients, package leaflet, QRD templates
2 Comments
Legalese in medical translation: a problem paragraph solved
How to tackle a legal paragraph in a medical text? Ask a colleague! Continue reading
Posted in Medical, Regulatory, Spanish-English translation
Tagged AEMPS, clinical trial, legal terminology, medical translation, terminology
5 Comments
AEMPS, CEIm and REec: 3 terms in Spanish Royal Decree 1090/2015
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 abbreviations, AEMPS, clinical trial, Royal Decree
4 Comments
Two webinar videos on EMA templates
News of two September webinars for medical translators. Continue reading
Posted in Medical, Regulatory
Tagged EDQM, EMA, MedDRA, medical translation, QRD templates, webinar
17 Comments
Brexit, Clinical Trials and Medical Translators
Changes in clinical trial regulations in post-Brexit UK. How will medical translators be affected? Continue reading
MedDRA: new version 19.0
News of the March 2016 update to the MedDRA terminology databases Continue reading
Posted in Medical, Regulatory, Spanish-English translation, Terminology
Tagged dictionaries, English, español, inglés, MedDRA, medical translation, spanish, terminology
2 Comments
An introduction to MedDRA for medical translators
Medical translators need to be conversant with MedDRA. Are you? Continue reading
How to align any EU legislation in any two EU languages
A description of two methods to align the new Clinical Trials Regulation (or any other EU legislation) Continue reading
New terminology for a new regulation
Are you conversant with the new definitions in the EU Clinical Trials regulation? Continue reading
Signs & Symptoms of Translation 