ADRs: a new EMA website and a terminology review

Adverse Drug Reaction reporting

Clindamycin rash

EMA, the European Medicines Agency, has recently launched a new website giving public access to the European database of suspected adverse drug reaction (ADR) reports. The website provides an A-Z list of reports that have been submitted to EudraVigilance by national medicines regulatory authorities. The list is classified by product and substance.

For medical translators the new website offers a good opportunity to brush up on terms and definitions used in ADR reporting, so the rest of this post is a brief review of ADR terminology in the form of a Q&A section.  Read more…

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A translator’s guide to the EMA templates

Last week an agency asked me if I would write some instructions for their medical translators about using EMA-QRD templates in their work. I thought I would share my ideas with you. Read more…

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

By way of introduction

Welcome to my new blog!

After reading lots about “Why you should be blogging” and “Why you shouldn’t be blogging” I’ve finally decided to take the plunge. Karen Tkaczyk very nearly succeeded in putting me off a couple of weeks ago with her excellent guest post on The case against bloggingRead more…

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