GLSP Translation Workshop
Implementing Good Lay Summary Practice
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.
Registration Fee(s)
- 250,00 € - Industry
- Free - Academia ethics committees, regulatory authorities, NGOs, societies
Programme
Monday 27 June 2022
| 14:00 |
Welcome and introduction to the GLSP Translation Workshop and results from registration survey |
| 14:15 |
GLSP translation procedure, language qualifications and language assets |
| 14:30 |
Case Studies/Translation Approach |
|
Sponsor representative |
|
|
Sponsor representative |
|
|
Patient representative |
|
|
Translation service provider |
|
| 15:30 |
BREAK |
| 15:45 |
Break-Out Sessions - Interactive Workshop |
|
Breakout Session 1: GLSP Language Toolbox |
|
|
Breakout Session 2: Patient/user involvement |
|
| 16:45 |
Break |
| 17:00 |
Joint Open Forum Discussion |
| 17:45 |
Wrap Up |
| 18:00 |
End of the Workshop |