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