Tag Archives: EMA

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

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

A translator’s guide to the EMA templates

Posted on 24 May 2012 by Emma Goldsmith

How to use the European Medicines Agency QRD templates to translate a Summary of Product Characteristics or Package Leaflet for a medicinal product. Continue reading →

Posted in Medical, Regulatory, Terminology | Tagged , , , , , , , | 29 Comments