EMA/HMA Big Data Stakeholder Forum 2022
Table of contents
The European medicines regulatory network is organising third, annual multi-stakeholder forum on big data to foster collaboration and engage stakeholders.
The objectives of this meeting include to:
- inform stakeholders on the delivery of data activities of the Network Strategy 2025;
- strengthen engagement and collaboration with stakeholders;
- look through a medicines regulatory lens to the European Health Data Space (EHDS).
At certain points throughout the meeting, participants will be able to give their input via the audience interaction tool Slido. Please go to www.slido.com, enter the event code “bdforum2022” and passcode “xe6w13”. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you chose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido.
Attendance is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate.
The meeting will be broadcast live on this web page and a video recording will be made available afterwards.
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Agenda - EU Big Data Stakeholder Forum (PDF/183.92 KB)
First published: 28/10/2022
Last updated: 30/11/2022
EMA/724391/2022 -
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Report - EMA/HMA Big Data Stakeholder Forum 2022 (PDF/180.56 KB)
First published: 01/02/2023
EMA/919710/2022 -
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Session 1 - Overview of 2022 deliverables and the new plan for 2022-2025 (Peter Arlett) (PDF/1.74 MB)
First published: 13/12/2022 -
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Session 2-1 - DARWIN EU ® – first experiences and regulatory use case (Xavier Kurz) (PDF/978.75 KB)
First published: 13/12/2022 -
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Session 2-2 - HTA DARWIN use case examples (Niklas Hedberg) (PDF/646.75 KB)
First published: 13/12/2022 -
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Session 2-3 - Payers DARWIN Use case examples (Wim Goettsch) (PDF/414.53 KB)
First published: 13/12/2022 -
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Session 2-4 - EU Data Quality Framework for medicines regulation – launch and collaboration (Ana Cochino) (PDF/1.25 MB)
First published: 13/12/2022 -
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Session 3-1 - EU Real World metadata list, good practice guide and catalogues of data sources and studies (Katerina Deli) (PDF/742.13 KB)
First published: 13/12/2022 -
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Session 3-2 Artificial Intelligence in Medicines Regulation (Gabriel Westman) (PDF/446.5 KB)
First published: 13/12/2022 -
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Session 3-3 Regulatory capability to analyse data - Clinical trial raw data (Joerg Zinserling) (PDF/678.71 KB)
First published: 13/12/2022 -
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Session 4-1 European Health Data Space (Jerome De Barros) (PDF/392.7 KB)
First published: 13/12/2022 -
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Session 4-2 -Towards European Health Data Space (TEHDAS) (Shona Cosgrove) (PDF/501.28 KB)
First published: 13/12/2022 -
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Session 4-3 - EHDS2 (Pilot Mario Jendrossek) (PDF/1.09 MB)
First published: 13/12/2022 -
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Session 4-4 - Implementation status of the ERMN Data standardization strategy (Nick Halsey) (PDF/607.02 KB)
First published: 13/12/2022 -
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Session 4-5 - Collaboration on international initiatives (Sean Barry) (PDF/793.82 KB)
First published: 13/12/2022 -
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Session 4-6 - RWE international collaboration and next steps (Melissa Kampman) (PDF/400.63 KB)
First published: 13/12/2022 -
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Session 4-7 - Advanced analytics to support animal and public health - Report from the 2nd Veterinary Big Data Stakeholders Forum (Ilaria Del Seppia) (PDF/358.5 KB)
First published: 13/12/2022 -
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Session 5-1 - EU Research & Innovation activities (Christina Kyriakopoulou) (PDF/2.66 MB)
First published: 13/12/2022 -
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Session 5-2 - Preparing for the future horizon scanning for big data topics (Ralf Herold) (PDF/527.77 KB)
First published: 13/12/2022 -
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Workplan 2022-2025 - HMA / EMA joint Big Data Steering Group (PDF/306.05 KB)
First published: 28/07/2022 -
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Big Data Steering Group (BDSG): 2021 report (PDF/382.67 KB)
First published: 15/03/2022
EMA/40400/2022