A common data model in Europe? – Why? Which? How?
This meeting will aim to define the opportunities and challenges in applying a common data model in Europe to support regulatory decision-making and agree guiding principles for the development of such a model, including key criteria for validation in the context of regulatory decision-making. A common data model could help harmonise healthcare data across multiple data sets and provide a mechanism to conduct pan-European studies in a timely manner to address regulatory questions. At the same time, applying a common model to European data has multiple challenges. The meeting will bring together regulators with academia, data holders and the pharmaceutical industry.
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A common data model for Europe - Why? Which? How? - Workshop report (PDF/804.24 KB)
First published: 08/10/2018
EMA/614680/2018 -
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Agenda - A common data model for Europe? – Why? Which? How? (PDF/447.17 KB)
Draft
First published: 31/10/2017
Last updated: 12/12/2017
EMA/550682/2017 -
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Presentation - A European common data model? Why? Which and how? - meeting objectives (Alison Cave) (PDF/725.66 KB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 1: A regulatory perspective: what do I want to know? (June M Raine) (PDF/2.61 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 1: FDA experience with the sentinel common data model: addressing data sufficiency (Michael D. Nguyen) (PDF/1.56 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 1: Use of real world data pre-authorisation – what can it answer? (Peter Mol) (PDF/556.45 KB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 1: A common data model - Why? Strengths and limitations of a common data approach (Patrick Ryan) (PDF/690.08 KB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: Comparing the use of OMOP and sentinel common data models for drug safety - Implications for European data (Andrew Bate) (PDF/1.21 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: The FDA sentinel common data model (Jeffrey Brown) (PDF/1.34 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: Case study: challenges faced by EMIF in utilising the OMOP common data model (Johan van der Lei) (PDF/2.79 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: Applying the sentinel common data model to electronic medical records: PCORnet Experience (Lesley H Curtis) (PDF/1.25 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: Challenges faced by Europe in implementing a common data model (Olaf Klungel) (PDF/1.8 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 2: Overview of the OMOP common data model (Peter Rijnbeek) (PDF/1.96 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 3: Data quality checking and validation of the sentinel common data model and tools (Jeffrey Brown) (PDF/1.65 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 3: OMOP common data model: validation approach (Jon Duke) (PDF/4.52 MB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 3: A regulatory approach to validation of the common data model (J. Slattery) (PDF/145.43 KB)
First published: 09/01/2018
Last updated: 09/01/2018 -
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Presentation - Session 3: CNODES common data model pilot project: challenges and opportunities (Robert Platt) (PDF/361.54 KB)
First published: 09/01/2018
Last updated: 09/01/2018