EU Labelling Requirements
EU Labelling Requirements

Original presentation date: March 2019

Course overview

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

To understand:

  • 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

Presenter 

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

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Price 

Members: £70+VAT

Non-members: £95+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. Please note, if you select the pay later option, you will not have access until payment has been cleared.

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.
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