Category Archives: Regulatory

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