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
12 & 13 Dec. 2022 12 & 13 Dec. 2022
4h30 / day 4h30 / day
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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
13:30 Patients’ involvement in Good Lay Summary Practice
Thomas Smith, EUPATI Fellow
Outi Saramäki, Laurea University of Applied Sciences
14:00 Medicines development strategies for different types of medicinal products
Birka Lehmann, Consultant, EUPATI Course Faculty Member
15:00 Break
15:20 Scientific questions in different phases of clinical development
Brigitte Franke-Bray, IFAPP
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
16:45 Scientific, ethical and methodological challenges in paediatric clinical trials
Begonya Nafria Escalera, San Joan de Déu
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
14:00 Ethical challenges in different trial designs
Ingrid Klingmann, EFGCP
14:30 Benefit-risk balance in clinical trials from a patient perspective
Dominique Hamerlijnck, ZonMW, EUPATI Fellow
15:00 Judgement on acceptable burdens for patients in different areas of indication
Tamás Bereczky, Patvocates
15:30 Break
15:50 Patient population definition between standardisation and diversity
Kerstin Breithaupt-Grögler, AGAH
16:20 Requirements for Lay Summary translations
Pia Windelov, Sealion Consult
16:50 Lay Summary dissemination options
Malgorzata Sztolsztener, AstraZeneca
17:20 Joint discussion: The spectrum of patient competence levels from user insights/user testing to writing of Lay Summaries
Lotte Klim, Novo Nordisk
17:45 End of Day 2