EMA multi-stakeholder workshop on qualification of novel methodologies
Table of contents
EMA is organising a multi-stakeholder workshop on qualification of novel methodologies. Qualification of novel methodologies was introduced in 2008. Ever since, it has provided a platform for iterative prospective discussion and agreement of evidence generation plans for future qualification (Qualification Advice), as well as for agreement and publication of scientific opinions once a novel methodology has been demonstrated to be valid to inform regulatory decision making (Qualification Opinion). The workshop will bring together academia, learned societies, public-private partnerships, consortia, patients, HTA bodies, regulators and industry to explore the scope, process and outcomes of the qualification of novel methodologies platform.
The aims of the workshop are to:
- confirm the future scope of qualification of novel methodologies in the light of ever accelerating development of science and technologies, to best support translation of innovation into patient benefit;
- look at use case examples of different methodologies, share procedural experiences and solicit input from stakeholders to identify recommendations to future proof the qualification of novel methodologies process and its outcomes.
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Agenda - EMA multi-stakeholder workshop on qualification of novel methodologies (PDF/412.99 KB)
First published: 13/03/2023
Last updated: 14/04/2023 -
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Introduction (Thorsten Vetter) (PDF/582.36 KB)
First published: 24/05/2023 -
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Presentation - The journey of innovation (Ana Drmic) (PDF/1.83 MB)
First published: 24/05/2023 -
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Presentation - The Pharma perspective (Solange Corriol-Rohoul) (PDF/928.28 KB)
First published: 24/05/2023 -
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Presentation - EU public-private funded project landscape (Nathalie Seigneuret (IHI)) (PDF/357.22 KB)
First published: 24/05/2023 -
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Presentation - Development of a PRO for upper limb function (Elizabeth Vroom) (PDF/2.47 MB)
First published: 24/05/2023 -
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Presentation - Qualifying PROs for rheumatology studies – update from EULAR (Robert B.M. Landewé) (PDF/909.71 KB)
First published: 24/05/2023 -
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Presentation - Regulatory perspective (Elmer Schabel) (PDF/683.94 KB)
First published: 24/05/2023 -
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Presentation - Regulatory perspective on qualification of Modelling and Simulation based methods (Flora Musuamba Tshinanu) (PDF/2 MB)
First published: 24/05/2023 -
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Presentation - Digital measures of nocturnal scratch (Cathelijne de Gram) (PDF/586.96 KB)
First published: 24/05/2023 -
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Presentation - AI-based pathology tools to improve clinical evidence (Katy Wack) (PDF/1.19 MB)
First published: 24/05/2023 -
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Presentation - Regulatory perspective (Joerg Zinserling) (PDF/746.71 KB)
First published: 24/05/2023 -
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Presentation - The Notified Bodies perspective (Daniela Seneca) (PDF/4.68 MB)
First published: 24/05/2023 -
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Presentation - Regulatory perspective (Peter Mol) (PDF/3.3 MB)
First published: 24/05/2023 -
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Presentation - The Cystic Fibrosis experience (Lutz Naehrlich) (PDF/371.98 KB)
First published: 24/05/2023 -
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Presentation - The TREAT-NMD experience (Neil Bennett TREAT-NMD) (PDF/2.9 MB)
First published: 24/05/2023