A common data model in Europe? – Why? Which? How?

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Date: maandag, 11 december 2017, Hele dag
Locatie: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

A common data model for Europe - Why? Which? How? - Workshop report

Reference Number: EMA/614680/2018

English (EN) (804.24 kB - PDF)

Publicatiedatum: 08/10/2018

Agenda - A common data model for Europe? – Why? Which? How?

Draft Reference Number: EMA/550682/2017

English (EN) (447.17 kB - PDF)

Publicatiedatum: 31/10/2017 Laatst gewijzigd: 12/12/2017

Presentation - A European common data model? Why? Which and how? - meeting objectives (Alison Cave)

English (EN) (725.66 kB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 1: A regulatory perspective: what do I want to know? (June M Raine)

English (EN) (2.61 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 1: FDA experience with the sentinel common data model: addressing data sufficiency (Michael D. Nguyen)

English (EN) (1.56 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 1: Use of real world data pre-authorisation – what can it answer? (Peter Mol)

English (EN) (556.45 kB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 1: A common data model - Why? Strengths and limitations of a common data approach (Patrick Ryan)

English (EN) (690.08 kB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: Comparing the use of OMOP and sentinel common data models for drug safety - Implications for European data (Andrew Bate)

English (EN) (1.21 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: The FDA sentinel common data model (Jeffrey Brown)

English (EN) (1.34 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: Case study: challenges faced by EMIF in utilising the OMOP common data model (Johan van der Lei)

English (EN) (2.79 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: Applying the sentinel common data model to electronic medical records: PCORnet Experience (Lesley H Curtis)

English (EN) (1.25 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: Challenges faced by Europe in implementing a common data model (Olaf Klungel)

English (EN) (1.8 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 2: Overview of the OMOP common data model (Peter Rijnbeek)

English (EN) (1.96 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 3: Data quality checking and validation of the sentinel common data model and tools (Jeffrey Brown)

English (EN) (1.65 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 3: OMOP common data model: validation approach (Jon Duke)

English (EN) (4.52 MB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 3: A regulatory approach to validation of the common data model (J. Slattery)

English (EN) (145.43 kB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Presentation - Session 3: CNODES common data model pilot project: challenges and opportunities (Robert Platt)

English (EN) (361.54 kB - PDF)

Publicatiedatum: 09/01/2018 Laatst gewijzigd: 09/01/2018

Multimedia