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.

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.

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

To purchase your seat at this session please click on the "buy" button. Available slots are limited and will be assigned to registered and paid participants as soon as payment is reported. Early payment is advised in order to secure participation. Allow some time for payment processing if you are paying by wire transfer.

After your payment is received, your status will be changed to “registered and paid” and your spot for the session will be secured. An invoice and receipt of payment will be sent to you for your records.

How do I access the online platform?

72 hours before the webinar takes place, you will receive an invitation to join the session. Please, click the registration link or button provided in the invitation email and complete the registration form.

For PC-based Users:

• Required: Windows 7 – Windows 10
• Required: Google Chrome v39 or later; Mozilla Firefox v34 or later; Internet Explorer v8 or later (JavaScript™ and Java™ enabled)
• Required software: GoToWebinar desktop app; JavaScript enabled
• NOT required: Microphone - attendees can communicate with the trainer through incorporated chat.

• Internet Connection Required: 1 Mbps or better (broadband recommended)
• Recommended: 2GB or more of RAM (recommended)


For Mac®-based Users:

• Mac OS X 10.8 (Mountain Lion) – 10.11 (El Capitan)
• Required: Microsoft Edge; Apple Safari v6 or later
• Required software: GoToWebinar desktop app; JavaScript enabled
• NOT required: Microphone - attendees can communicate with the trainer through incorporated chat.

• Internet Connection Required: 1 Mbps or better (broadband recommended)
• Recommended: 2GB or more of RAM (recommended)

Join from Android

• Operating system: Android 4.0 (Ice Cream Sandwich) or later
• Internet connection: 3G connection or better (WiFi recommended for VoIP audio)
• Software: Free GoToWebinar App from the Google Play Store



Recommendations

• For the visual section of the training course, we recommend that you have a 64kbps link. This means using an ISDN line or Broadband. Wireless connection is NOT recommended.
• For the audio section of the training course, we recommend that you have a headset or speakers.
• We recommend that you log in 30 minutes in advance of the start time to prepare for the training course.

Courses will be open half an hour before the start time. Please login before the start time to ensure that everything on your system is working correctly.

 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).