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.

No prerequisites.

Overview of drug leaflets, packaging and labelling
Regulatory references and templates
Gathering, evaluating, organising, interpreting and presenting
FDA/EMA regulations
Translation and in-country review
Terminology review and references

Price: 20.00 USD
Click on the buy button on the right to purchase your seat

Participation fee includes unlimited access to the recording and handouts provided by the trainer.

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To purchase your seat at this session please click on the "buy" button. After your payment is received, your status will be changed to “registered and paid” and an invoice and receipt of payment will be sent to you for your records.

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Once the payment is processed you will be able to watch the video here.

How do I access handouts?

Follow the link on the top right corner as suggested here.

Where can I find a certificate of attendance?

A certificate of attendance can be issued upon training completion and as per your request. A certificate of attendance can be downloaded at http://www.proz.com/profile/?show_mode=standard#trainings

 Erin Lyons    View feedback | View all courses

Bio: 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).