Webinar: EU Labelling Requirements

Webinar: EU Labelling Requirements
This webinar will look at the steps involved in the EMA’s Linguistic Review procedure of product information following MA or post-authorisation procedures for centrally authorised products and how to efficiently manage the process.

Date: Thursday 28 March 2019
Time: 12.00 - 13.00 (GMT)


This webinar will cover:

  • Organisation of translations of new, or updated, PI in all EU languages according to EMA QRD templates and stylistic requirements
    • How to communicate and work with translation agencies and/or local translators including relevant training in QRD requirements
    • Effective transfer and tracking of updated translations – use of IT tools
  • Co-ordination of review and QC of translations, including liaison with local company affiliates in involved markets
    • How to facilitate effective and accurate checks
    • Liaison with MS - how to collate and implement amendments accurately
    • Use of software applications to ensure accurate content and formatting
  • Submission of translations
    • Compliance with timelines and document requirements for MS and QRD

Learning objectives 

  • Key steps and requirements of Linguistic Review
  • How to facilitate an effective Linguistic Review procedure
  • Tips on how to meet deadlines of Linguistic Review timetables
  • Formatting and publishing requirements of final translations

Target audience  

This webinar is for any personnel involved in centralised procedures (MAA and post-authorisation) for which updates to the PI are included; there are some for which LR are not required; however, for these translations have to be completed and QCd, so part of the procedure is still relevant


Karen Goode is a Director at EUDRAC Ltd, a regulatory and pharmacovigilance consultancy.  Karen has worked in the pharmaceutical industry since 1991,  firstly in clinical research and project management for Hoechst and then for Stiefel International, a specialist dermatology company. She then began working in regulatory affairs for both medicinal products and medical devices at Stiefel before moving to GSK.

Karen joined EUDRAC Ltd in 2011 and has worked on numerous projects at different stages of drug development (eg, scientific advice, orphan drug designation, marketing authorisation application) and post-authorisation lifecycle maintenance. These have included a large number of linguistic review procedures, for which Karen has been involved in developing the processes and software that EUDRAC implement across the variety of marketing authorisation procedures for which linguistic review is required to facilitate an efficient and high quality process. EUDRAC has been conducting Linguistic Review procedures for more than eight years and, to date, has completed over 140 procedures


This course offers 1 CPD hour for successful completion. To learn about why CPD is important visit our Lifelong Learning page.

How do I apply?

Simply log in or create an account and register below. 

Course fees:
Type Member  Non-member 
Standard    £70+VAT £95+VAT 


Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.

At Your Desk ONLINE
Your VAT country
Your Vat number
If your company VAT number does not appear here or you would like to be invoiced using a different VAT number please email finance@topra.org

Register now