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

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TitleA common data model in Europe? – Why? Which? How?
Date11/12/2017 - 12/12/2017
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

Name Language First published Last updated
Agenda - A common data model for Europe? – Why? Which? How? (English only) 2017-10-31 2017-12-12
Presentation - A European common data model? Why? Which and how? - meeting objectives (Alison Cave) (English only) 2018-01-09  
Presentation - Session 1: A regulatory perspective: what do I want to know? (June M Raine) (English only) 2018-01-09  
Presentation - Session 1: FDA experience with the sentinel common data model: addressing data sufficiency (Michael D. Nguyen) (English only) 2018-01-09  
Presentation - Session 1: Use of real world data pre-authorisation – what can it answer? (Peter Mol) (English only) 2018-01-09  
Presentation - Session 1: A common data model - Why? Strengths and limitations of a common data approach (Patrick Ryan) (English only) 2018-01-09  
Presentation - Session 2: Comparing the use of OMOP and sentinel common data models for drug safety - Implications for European data (Andrew Bate) (English only) 2018-01-09  
Presentation - Session 2: The FDA sentinel common data model (Jeffrey Brown) (English only) 2018-01-09  
Presentation - Session 2: Case study: challenges faced by EMIF in utilising the OMOP common data model (Johan van der Lei) (English only) 2018-01-09  
Presentation - Session 2: Applying the sentinel common data model to electronic medical records: PCORnet Experience (Lesley H Curtis) (English only) 2018-01-09  
Presentation - Session 2: Challenges faced by Europe in implementing a common data model (Olaf Klungel) (English only) 2018-01-09  
Presentation - Session 2: Overview of the OMOP common data model (Peter Rijnbeek) (English only) 2018-01-09  
Presentation - Session 3: Data quality checking and validation of the sentinel common data model and tools (Jeffrey Brown) (English only) 2018-01-09  
Presentation - Session 3: OMOP common data model: validation approach (Jon Duke) (English only) 2018-01-09  
Presentation - Session 3: A regulatory approach to validation of the common data model (J. Slattery) (English only) 2018-01-09  
Presentation - Session 3: CNODES common data model pilot project: challenges and opportunities (Robert Platt) (English only) 2018-01-09  

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