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 Vista – 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. Created by Erin Lyons View feedback | View all courses
General discussions on this training
| Course registration To view pricing and payment options for this course, you must login to your ProZ.com account. Do you have any questions about ProZ.com training? Read the training FAQ » Still need help? Submit a support request » Would you like to share your thoughts about the ProZ.com training platform? Click here to discuss this feature in the forums » Feedback on this course (3)
|
You can request verification for native languages by completing a simple application that takes only a couple of minutes.
Review native language verification applications submitted by your peers. Reviewing applications can be fun and only takes a few minutes.
View applications