Technical workshop on real-world metadata for regulatory purposes
Table of contents
Date:
12/04/2021
Location:
Virtual meeting
Data characterization and discoverability are goals for the scientific community and for medicines regulation. The HMA-EMA joint Big Data Task Force recommended “to promote data discoverability through the identification of metadata” as part of its Recommendation III, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to review and gather stakeholders’ feedback on:
- preliminary list of metadata required for characterising real-world data sources and definitions to fulfil regulatory use cases;
- proposed options for metadata from real-world data sources collection and maintenance processes;
- proof-of-concept catalogue of data sources and metadata.
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Agenda - Technical workshop on real-world metadata for regulatory purposes (PDF/620.23 KB)
Adopted
First published: 22/03/2021
Last updated: 14/04/2021
EMA/139729/2021 -
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Presentation - Technical workshop on real-world metadata for regulatory purposes - Opening remarks (Nikolai Brun) (PDF/323.01 KB) (new)
First published: 10/05/2021 -
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Presentation - Overview of the project Metadata for data dIscoverabilityaNdstudy rEplicabilityin obseRVAtionalstudies (MINERVA) (EMA/2017/09/PE/16) (Susana Perez-Gutthann) (PDF/802.19 KB) (new)
First published: 10/05/2021 -
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Presentation - Overview of the HMA-EMA Big Data Taskforce priority 3: recommendation to enable data discoverability (Stefania Simou) (PDF/509.88 KB) (new)
First published: 10/05/2021 -
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Presentation - Stakeholders feedback from pre-meeting survey: Session 1 Feedback process overview (Susana Perez-Gutthann) (PDF/228.07 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 1: Overview of the regulatory use case (Romin Pajouheshnia) (PDF/5.61 MB) (new)
First published: 10/05/2021 -
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Presentation - Session 1: Overview of the regulatory use case (Romin Pajouheshnia) (PPTX/10.19 MB) (new)
First published: 10/05/2021 -
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Presentation - Session 1: Conceptual framework (Rosa Gini) (PDF/995.8 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 2: Preliminary list of metadata (Romin Pajouheshnia) (PDF/544.57 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 2: Stakeholders feedback from pre-meeting survey: metadata (Romin Pajouheshnia) (PDF/246.86 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 3: FAIR catalogue sustainability (Miriam Sturkenboom) (PDF/729.33 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 3: Stakeholders feedback from pre-meeting survey: sustainability & collection (PDF/271.28 KB) (new)
First published: 10/05/2021 -
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Presentation - Session 4: Preliminary proof-of-concept catalogue tool (Morris Swertz) (PDF/1.86 MB) (new)
First published: 10/05/2021 -
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Presentation - Session 4: Stakeholders feedback from pre-meeting survey: proof-of concept catalogue tool (Morris Swertz) (PDF/241.52 KB) (new)
First published: 10/05/2021