Learnings initiative webinar for optimal use of big data for regulatory purpose
Table of contents
Regulators need to continuously assess big data in combination with novel methodologies to take decisions on individual products that need to be based on comprehensive, valid and reliable evidence. Use of big data has however introduced new challenges and uncertainties around the quality of an increasing volume of complex data, new analytical approaches, new processes and the need for additional expertise and guidance. The Big Data Task Force Report - Phase 2 emphasised that assessment of big data requires continuous optimisation of current standards and specifications to provide all stakeholders with rules and guidance supporting evidence generation.
Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous workshops on data standardisation, metadata and artificial intelligence organised by the Agency, this webinar aims to:
- learn from current experience of using real-world data for regulatory purpose
- discuss important challenges related to optimal use of real-world data, including data relevance, submission processes and training needs
- discuss means to support effective consultation with stakeholders, including industry, the regulatory network, academia, healthcare professionals and patients.
The webinar recommendations will be fed back into internal processes, stakeholder consultations, support for individual product submission and ultimately guidelines for applicants and the regulatory network.
The event will be broadcast.
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Meeting report - Learnings initiative webinar for optimal use of big data for regulatory purpose (PDF/260.9 KB)
First published: 28/01/2022
Last updated: 03/02/2022
EMA/18271/2022 -
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Draft agenda - Learnings initiative webinar for optimal use of big data for regulatory purpose (PDF/539.51 KB)
Draft
First published: 28/10/2021
Last updated: 23/11/2021 -
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Presentation - FDA Guidance on real-world data (John Concato) (PDF/2.01 MB)
First published: 14/12/2021 -
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Presentation - CHMP guideline on registry-based studies (Kelly Plüschke) (PDF/181.59 KB)
First published: 14/12/2021 -
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Presentation - Breakout session 2: Platform for stakeholders’ consultation (EFPIA) (PDF/447.47 KB)
First published: 14/12/2021 -
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Presentation - Breakout session 2: Platform for stakeholders’ consultation (Marie-Helene Pinheiro) (PDF/309.43 KB)
First published: 14/12/2021 -
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Presentation - Breakout session 3: Process optimisation (Andrej Segec) (PDF/822.67 KB)
First published: 14/12/2021 -
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Presentation - Breakout session 4: Training and expertise (Gianmario Candore, Stefania Simou) (PDF/304.88 KB)
First published: 14/12/2021 -
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Presentation - Lessons learned from the applications submitted to EMA for marketing authorisation and extension of indication, 2018- 2019 (Elisabeth Bakker) (PDF/755.61 KB)
First published: 14/12/2021 -
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Presentation - Breakout session 5 - Heterogeneity of results between data sources (Catherine Cohet) (PDF/1.77 MB)
First published: 14/12/2021 -
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Presentation - The role of RWE in FDA approvals (J. Rassen) (PDF/1.09 MB)
First published: 14/12/2021 -
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Presentation - Plenary session 1: Pharmaceutical industry’s experience and challenges with RWE submission in marketing authorisation applications (PDF/340.36 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 1: The Charybdis project – Use of real-world data from multiple countries and opportunities for regulatory purpose (Talita Duarte-Salles) (PDF/1.52 MB)
First published: 14/12/2021 -
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Presentation - Introduction to the breakout sessions (Xavier Kurz) (PDF/594.46 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 1: Report from the breakout session 1: Fitness of real-world data for regulatory purpose (Kelly Plueschke) (PDF/123 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 2: Report from the breakout session 2: Platform for stakeholders’ consultation (Carla Jonker) (PDF/116.49 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 2: Report from the breakout session 3: Process optimisation (Andrej Segec) (PDF/138.45 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 2: Report from the breakout session 4: Training and expertise (PDF/97.64 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 2: Report from the breakout session 5: Heterogeneity of results between data sources (Daniel Prieto-Alhambra) (PDF/131.29 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 3: Wrap-up and next steps (Jesper Kjær) (PDF/282.61 KB)
First published: 14/12/2021 -
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Presentation - Concluding remarks (Peter Arlett) (PDF/140.1 KB)
First published: 14/12/2021 -
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Presentation - Plenary session 3: Analysis and interpretation of realworld data: A 5-year outlook (Patrick Ryan) (PDF/2.51 MB)
First published: 14/12/2021