Where Regulatory Rules: Translating Drug Leaflets, Packaging and Labelling
Course summary
Description 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. Prerequisites No prerequisites. Program 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 Registration and payment information (click to expand) Click to expand 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. Virtual platform system requirements Click to expand For PC-based Users: • Required: Windows® 8, 7, Vista, XP or 2003 Server • Required: Internet Explorer® 7.0 or newer, Mozilla® Firefox® 3.0 or newer or Google™ Chrome™ 5.0 or newer (JavaScript™ and Java™ enabled) • Internet Connection Required: Cable modem, DSL, or better Internet connection • Recommended: Dual-core 2.4GHz CPU or faster with 2GB of RAM (recommended) For Mac®-based Users: • Required: OS X 10.7 Lion, 10.8 Mountain Lion, 10.9 Mavericks and 10.10 Yosemite • Required: Safari™ 3.0 or newer, Firefox® 3.0 or newer or Google™ Chrome™ 5.0 or newer (JavaScript™ and Java™ enabled) • Internet Connection Required: Cable modem, DSL, or better Internet connection • Required: Intel processor (1GB of RAM or better recommended) To Use VoIP (microphone and speakers or headset): • Required: Fast Internet connection (384 kbps or more recommended) • Required: speakers or headset (USB headset recommended) • NOT required: Microphone - attendees can communicate with the trainer through incorporated chat. 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. Created by Erin Lyons View feedback | View all courses
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