Tag Archives: EMA

EMA updates SmPC and package leaflet templates with new black symbol

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

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

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MHRA Good Clinical Practice Guide

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

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

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ADRs: a new EMA website and a terminology review

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

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