Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use
Table of contents
Date:
26/06/2023 to 27/06/2023
Location:
European Medicines Agency and online
Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®, this workshop aims to:
- Discuss important challenges related to measuring and characterising data quality in the context of RWE generation.
- Familiarise stakeholders with the approach used in drafting of considerations on Real-World Data linked to the EU Data Quality Framework.
- Discuss recent use of RWE in the regulatory context and share lessons learned.
- Look back at the European Medicines Regulatory Network response to the COVID-19 pandemic and reflect on learnings and impact on the way we use RWE to address public health emergencies.
- Collect input from experts in the field and learn from existing experiences.
- Get multi-stakeholders’ input to identify ways to enable further use and continue to establish the value of RWE in regulatory processes.
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Agenda - Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use (PDF/309.11 KB)
First published: 26/05/2023
Last updated: 26/06/2023 -
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Report - Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use (PDF/211.46 KB) (new)
First published: 29/09/2023
EMA/EMA/392935/2023 -
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Presentation - The EU Pharmaceutical Reform (S. Rafael Almeida, DG SANTE) (PDF/285.01 KB)
First published: 05/07/2023 -
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Presentation - TEHDAS Data Quality Framework: Excellence in data quality (E. Bernal Delgado, TEHDAS) (PDF/549.35 KB)
First published: 05/07/2023 -
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Presentation - EU Data Quality Framework and development of the RWD deep dive (A. Cochino, EMA) (PDF/691.71 KB)
First published: 05/07/2023 -
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Presentation - RWD Data Quality Experience in Finland (P. Rannanheimo, FIMEA) (PDF/598.48 KB)
First published: 05/07/2023 -
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Presentation - Real World Data (RWD) quality and experience Danish national health registers (S. Knudstrup, K. Holt Nielsen, Danish Health Data Authority) (PDF/1.78 MB)
First published: 05/07/2023 -
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Presentation - RWD Data Quality Experience in France (E. Bacry, Health Data Hub) (PDF/858.05 KB)
First published: 05/07/2023 -
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Presentation – RWD Data Quality Experience by Industry (K.H. Zou, Viatris) (PDF/508.3 KB)
First published: 05/07/2023 -
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Presentation - Systems and processes underpinning Real-World Data : Characterisation and maturity model consideration (A. Cochino, EMA) (PDF/270.4 KB)
First published: 05/07/2023 -
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Presentation - Data quality metrics in the context of DARWIN EU (M. Moinat, DARWIN EU Coordinating Centre) (PDF/1.11 MB)
First published: 05/07/2023 -
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Presentation - Data Quality metrics for Real-World Data (K.Deli, EMA) (PDF/263.95 KB)
First published: 05/07/2023 -
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Presentation - Data quality requirements and study design and analysis aspects (O. Klungel, Utrecht University) (PDF/969.75 KB)
First published: 05/07/2023 -
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Presentation - Data quality in fit for purpose assessments (J. Abellan, EMA) (PDF/225.08 KB)
First published: 05/07/2023 -
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Presentation - A report on the experience with regulatory led RWD studies (S. Prilla, EMA) (PDF/1.17 MB)
First published: 05/07/2023 -
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Presentation - Use of RWE in medicines development and regulatory submissions - an industry perspective (A. Spooner, AbbVie) (PDF/1.1 MB)
First published: 05/07/2023 -
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Presentation - Use of RWE in medicines development and regulatory submissions - a regulator’s perspective (C. Torre, University of Lisbon) (PDF/11.3 MB)
First published: 05/07/2023
Last updated: 10/07/2023 -
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Presentation - Survey results : Use (-fulness) of RWE in regulatory decisions (S. Prilla, EMA) (PDF/619.86 KB)
First published: 05/07/2023 -
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Presentation - DARWIN EU: where we are in the Phase 2 of its implementation (A. Segec, EMA) (PDF/1.41 MB)
First published: 05/07/2023 -
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Presentation - DARWIN EU to support HTA and payers’ research RWE needs (J. Abellan, EMA) (PDF/195.67 KB)
First published: 05/07/2023 -
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Presentation - DARWIN EU to support EHDS2 pilot (M. Jendrossek, EHDS) (PDF/1009.18 KB)
First published: 05/07/2023 -
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Presentation - DARWIN EU in the context of infectious diseases and health emergencies (E. Duffell, ECDC) (PDF/635.22 KB)
First published: 05/07/2023 -
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Presentation - Patient registries in regulatory decision making : Regulator’s vision and experiences (P. McGettigan, PRAC) (PDF/874.85 KB)
First published: 05/07/2023 -
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Presentation - Assessing the EMA data quality framework (DQF) dimensions using REQUeST: a decentralized registry use case (P. Dobay, Meritxell Sabidó) (PDF/367.46 KB)
First published: 05/07/2023 -
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Presentation - Registry based randomized clinical trials (R-RCT) - from SWEDEHEART to EuroHeart (L. Wallentin, Uppsala University) (PDF/6.09 MB)
First published: 05/07/2023 -
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Presentation - Survey results on the EMA guideline on registry based studies (K. Plueschke, EMA) (PDF/521.53 KB)
First published: 05/07/2023 -
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Presentation - Patient representative perspective - panel discussion (M. De Lemus, CAT) (PDF/213.97 KB)
First published: 05/07/2023 -
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Presentation - Measuring vaccine performance under emergency situations - case studies and learnings for RWE generation (M. Goossens, EMA) (PDF/453.21 KB)
First published: 05/07/2023