GLSP Translation Workshop

Implementing "Good Lay Summary Practice"

Workshop Workshop
27 June 2022 27 June 2022
4 hours 4 hours
Presentations & Recordings: Available for Event's Registered Participants only Presentations & Recordings: Available for Event's Registered Participants only

Description

The new EU Clinical Trial Regulation requires the development and dissemination of Lay Summaries for clinical trial results from commercial and non-commercial sponsors. The Good Lay Summary Practice (GLSP) Handbook, which was published under EudraLex Volume 10 in October 2021, recommends that these summaries are translated into local language for all countries in scope of the clinical trial protocol to make them accessible and understandable to their intended audiences. Translation is one of four key steps in the GLSP Handbook, and we invite sponsors, patient representatives and translation professionals to attend this workshop which will focus on the practical implementation of lay summary translations and user involvement. The outcomes of the workshop will be used to develop a “GLSP Language toolbox” that can provide best practices, tools, and training for sponsors to implement successful, seamless translations of lay summaries and user involvement.

Download Programme
Registration Fee(s)
  • 250,00 € - Industry
  • Free - Academia ethics committees, regulatory authorities, NGOs, societies

Programme

Day 1 - Monday 27th of June 2022
14:00 Welcome and introduction to the GLSP Translation Workshop and potential survey question
Pia Windelov, Lionbridge
14:15 GLSP translation procedure, language qualifications and language assets
Nataliya Volhov, Lionbridge
Pia Windelov, Lionbridge
14:30 Case Studies / Translation Approach
Sponsor representative
Julia Anna Gindele, Boehringer Ingelheim Thomas Schindler, BioNTech
Sponsor representative
David Davis, Novartis
Patient reviewer
Thomas Smith, EUPATI Fellow
Translation service provider
Samuel Aubin, mt-g medical translation
15.30 Break
15:45 Break-Out Sessions - Interactive Workshop
Breakout Session 1: GLSP Language Toolbox
Moderator: Pia Windelov, Lionbridge
Breakout Session 2: Patient/user involvement
Moderator: Nataliya Volhov, Lionbridge
16:45 Break
17:00 Joint open forum discussion
17:45 Thank you and closure of Workshop