Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling

Format: Videos
Topic: Medical translation

Course summary
Availability:This training is available on-demand

Duration: 55 minutes.

After you purchase access click here to watch the video.

Purchase four sessions for only 80 USD 68 USD today! See other sessions from the bundle below:

* On-demand training The Patient's Perspective: Best Practices for Translating ICFs and PILs

* On-demand training SOAP Notes and Medical Charts: The Nitty Gritty of Medical Reports

* On-demand training Medical Journals: Translating Like A Writer, Not A Scientist

* On-demand training Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling

Summary: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.
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.
Target audience
Translators already specialising in medical translation.
Translators considering crossing over into medical translation.
Medical translators interested in regulatory affairs.
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.
No prerequisites.
Click to expand
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
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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Created by
 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).
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Feedback on this course (3)
Extremely satisfied (5 out of 5)
"The contents and material of the course are very comprehensive and well-organized. Moreover, the tra..." Read more
Extremely satisfied (5 out of 5)
"21-Nov-19: Erin, love your knowledge and expertise! Very good content, very helpful!"
Very satisfied (4 out of 5)
"The course was very clear and helpful. The slides were very informative as well as the information g..." Read more

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