Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling


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59 minutes

Learning Objectives

  • At the end of this session, participants will be able:
  • To identify the essential components of drug leaflets, packaging and labelling.
  • To reference language- and locale-specific regulatory guidelines and templates.
  • To understand and participate in the translation, in-country review and post-marketing processes.
  • To compile a term management system and TM for regulatory-specific texts.


Are you stumped by drug leaflets and packaging translations? Does the extensive time spent researching regulatory requirements and templates make translating these documents not profitable? We will review the essential regulatory requirements, terminology and templates necessary to accurately and efficiently translate these highly regulated documents.
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Translating drug leaflets, packaging and labelling is a delicate and highly regulated process. Language- and locale-specific templates and terminology dominate and conventions vary between languages and countries (questions vs. affirmations, for example). In this webinar, the final in this four-part series on medical translation, we will review the regulatory resources, references and templates to effectively translate drug leaflets, packaging and labelling. You will learn to effectively gather, evaluate, organise, interpret and present data based on the source language and corresponding target FDA/EMA regulations. You will become familiar with the steps of the translation, in-country review and post-marketing review processes and how to negotiate "untranslatables". Finally, we will build a set of terminology review resources and references to ensure that translating regulatory medical documents is less research-driven and more profitable.

Upload Date

April 23, 2016

Trainer Bio

Erin Lyons - Erin M. Lyons is a full-time French to English and Italian to English translator, medical writer, and consultant and the Owner and President of BiomedNouvelle. Her primary areas of focus include clinical research, pharmaceuticals, medical devices, and cosmetic products and she has split her professional career between Europe and the U.S. She has a BA in Romance Languages and Literature from the University of Chicago and an MA in Italian and French Translation from the Monterey Institute of International Studies. She has presented at several ATA Annual Conferences, as well as at the 2011 World Congress of the International Federation of Translators and the 2013 ProZ.com International Conference (Porto) and 6th Annual Congress and Training in France (Biarritz).

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