Workshop on the draft guideline on registry-based studies
Table of contents
Date:
19/10/2020
Location:
Virtual meeting
This half-day virtual workshop will give an overview of the draft guideline on registry-based studies. Stakeholders will have the opportunity to discuss questions, perspectives on the usefulness of the document and recent experience on methodological aspects of registry-based studies, such as the use of a large registry for clinical trials.
EMA’s cross-committee task force has developed the draft guideline. It is open for public consultation until 31 December 2020. For more information, see the EMA Patient registries web page.
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Agenda - Workshop on the draft guideline on registry-based studies (PDF/623.65 KB)
First published: 07/09/2020
Last updated: 15/10/2020
EMA/428155/2020 -
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Guideline on registry-based studies (PDF/685.43 KB)
Draft: consultation closed
First published: 24/09/2020
Consultation dates: 24/09/2020 to 31/12/2020
EMA/502388/2020 -
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Submission of comments on ‘Guideline on registry-based studies’ (EMA/484811/2020) (DOC/231.5 KB)
First published: 24/09/2020 -
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Presentation - 1.3 Overview of core recommendations of the draft guideline and comments received (Xavier Kurz, Valerie Strassmann) (PDF/1.18 MB)
First published: 23/10/2020 -
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Presentation - 2.6 Industry perspective on registry (Chris Chinn) (PDF/958.8 KB)
First published: 23/10/2020 -
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Presentation - 2.6 Registry holders perspective (Eoin McGrath) (PDF/518.34 KB)
First published: 23/10/2020 -
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Presentation - 2.6 Patients association perspective (Mariette Driessens) (PDF/786.29 KB)
First published: 23/10/2020 -
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Presentation - 2.6 Regulators example MS registry (VMarion Haberkamp) (PDF/740.88 KB)
First published: 23/10/2020 -
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Presentation - 2.6 Stakeholder perspective regulator (Milena Stain) (PDF/342.21 KB)
First published: 23/10/2020 -
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Presentation - 3.8 Experience of randomisation within a registry (Barbara Casadei) (PDF/939.73 KB)
First published: 23/10/2020 -
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Presentation - 3.9 Data quality and data verification in registries - results of a stakeholders survey (Carla Jonker) (PDF/760.48 KB)
First published: 23/10/2020 -
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Presentation - 3.10 Survey on the collection of data on adverse events related to medicinal products through registries (Kelly Plueschke) (PDF/501.92 KB)
First published: 23/10/2020