Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling
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.
Translators already specialising in medical translation.
Translators considering crossing over into medical translation.
Medical translators interested in regulatory affairs.
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.
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Overview of drug leaflets, packaging and labelling
Regulatory references and templates
Gathering, evaluating, organising, interpreting and presenting
Translation and in-country review
Terminology review and references
Virtual platform system requirements
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Registration and payment information (click to expand)
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Price: 20.00 USD
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Erin Lyons View feedback | View all courses
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