Webinar: EU Labelling Requirements

The EUDRAC team is presenting a TOPRA webinar on the linguistic review process at the end of March.  We will share learning from our experience and also seek to impress upon attendees the high level of specialism that we have achieved from our work in the area.

The team has experience of more than 140 linguistic review procedures following Marketing Authorisation Applications (MAA), variations, renewals, Periodic Safety Update Reports and referrals and the complexity of parallel linguistic reviews.

Webinar details

This webinar will look at the steps involved in the EMA’s Linguistic Review procedure of product information following Marketing Authorisations  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)


Organisation of translations of new, or updated, product information 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 Member States - 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 Member States 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 product information are included; there are some for which linguistic review are not required; however, for these translations have to be completed and quality controlled, so part of the procedure is still relevant 

Learn more at http://bit.ly/2QgQ5Et