Patient Involvement in “Good Lay Summary Practice”
A 2-step Train-the-Trainer Initiative of the Roadmap Initiative to Good Lay Summary Practice
Training
Training
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12 & 13 Dec. 2022
12 & 13 Dec. 2022
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4h30 / day
4h30 / day
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Presentations & Recordings: Available for all logged in users, connect to your account to view the material
Presentations & Recordings: Available for all logged in users, connect to your account to view the material
Description
A 2-step Train-the-Trainer Initiative of the Roadmap Initiative to Good Lay Summary Practice
Jointly enabled by EFGCP, EFPIA and EUPATI
Step 1:
A 2-afternoons virtual training on 12 & 13 December 2022: Focus on deepening the knowledge about aspects of relevance to be presented in Lay Summaries
Free access for EUPATI Fellows and other patient advocates with expertise in clinical development methodology and interested in engaging in patient involvement in GLSP.
Step 2:
Invitation to participants in Step 1 willing to become a (national/regional) trainer in patients’ Lay Summary involvement to join in Brussels for a f2f training on 18 January 2023 in EFPIA.
Programme
Day 1 - Monday 12th of December 2022
13:15 |
Welcome and Introduction to the Training
Ingrid Klingmann, EFGCP
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13:30 |
Patients’ involvement in Good Lay Summary Practice
Thomas Smith, EUPATI Fellow
Outi Saramäki, Metropolia University of Applied Sciences
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14:00 |
Medicines development strategies for different types of medicinal products
Birka Lehmann, Consultant, EUPATI Course Faculty Member
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15:00 |
Break |
15:20 |
Scientific questions in different phases of clinical development
Brigitte Franke-Bray, IFAPP
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16:00 |
The different kind of endpoints in clinical studies and their contributions to the overall evidence with an introduction to the concept of estimands (and why they are relevant for patients)
Thomas Schindler, BioNTech
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16:45 |
Scientific, ethical and methodological challenges in paediatric clinical trials
Begonya Nafria Escalera, San Joan de Déu
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17:05 |
Joint discussion: Approaches to presenting these complex aspects in a Lay Summary Ingrid Klingmann, EFGCP |
17:45 |
End of Day 1 |
Day 2 - Tuesday 13th of December 2022
13:15 |
Welcome and introduction to today’s programme
Ingrid Klingmann, EFGCP
|
13:30 |
Traditional and modern study designs
Alessandra Veronese, BeiGene, EUPATI Patient Expert Italy
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14:00 |
Ethical challenges in different trial designs
Ingrid Klingmann, EFGCP
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14:30 |
Benefit-risk balance in clinical trials from a patient perspective
Dominique Hamerlijnck, ZonMW, EUPATI Fellow
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15:00 |
Judgement on acceptable burdens for patients in different areas of indication
Tamás Bereczky, Patvocates
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15:30 |
Break |
15:50 |
Patient population definition between standardisation and diversity
Kerstin Breithaupt-Grögler, AGAH
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16:20 |
Requirements for Lay Summary translations
Pia Windelov, Sealion Consult
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16:50 |
Lay Summary dissemination options
Malgorzata Sztolsztener, AstraZeneca
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17:20 |
Joint discussion: The spectrum of patient competence levels from user insights/user testing to writing of Lay Summaries
Lotte Klim, Novo Nordisk
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17:45 |
End of Day 2 |