Read the online version | ISSN 2811-7778
  December 2023  

Big Data Highlights

Quarterly update on implementing the joint HMA-EMA Big Data workplan
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The Heads of Medicines Agencies and the European Medicines Agency set up a joint Big Data Steering Group to implement the European medicines regulatory network’s Big Data workplan. The aim of the plan is to help prioritise and prepare concrete actions to make best use of big data in support of innovation and public health in the European Union.

Featured topics

Publication of Artificial Intelligence workplan to guide use of AI in medicines regulation

EMA and the Heads of Medicines Agencies (HMAs) have endorsed an Artificial Intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.
 
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News

Data Quality Framework sets the standard for health data

The final version of the Data Quality Framework for EU medicines regulation has been published following a public consultation. This guideline sets out the criteria for a more consistent and standardised approach to the quality of data used in medicine regulation to support benefit-risk decisions.
 
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Get ready for the launch of data sources and studies catalogues in February 2024!
The go-live date in February 2024 for the EMA-HMA catalogues of data sources and non-interventional studies is approaching. A downtime period of the ENCePP Resources Database and EU PAS Register is expected from 22 January to 15 February 2024 to enable preparation of the go-live.
 
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DARWIN EU® continues to scale up in its second year of establishment

DARWIN EU® is in the process of onboarding ten additional data partners to expand its capacity to deliver real-world evidence-based studies. These studies provide valuable insights to support regulatory decision-making throughout the lifecycle of a medicinal product.
 
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Real-world evidence and data sources training opportunities for regulatory network
We are pleased to announce the launch of the Big Data training curricula with the rollout of the first two modules related to the Pharmacoepidemiology and Real-World Evidence (RWE) domain.
 
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Events

Webinar on the Union Product Database Data Quality Framework, 11 January 2024
National competent authorities (NCAs) are invited to attend this session for a progress report on the UPD Data Quality Framework
Date
date 11/01/2024 - 11/01/2024
Venue
venue Online
 
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ACT EU Clinical Trials Analytics Workshop, 25-26 January 2024
Participants will share their use cases which might be addressed by access to clinical trials data, data analysis, and funding; provide input on evidence gaps within the EU clinical trials environment and be informed how international data standardisation efforts on clinical trials led by ICH M11 are enabling new use cases and support implementation.
Date
date 25/01/2024 - 26/01/2024
Venue
venue EMA and online
 
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HMA/EMA Multistakeholder Workshop on Patient Registries, 12-13 February 2024
The workshop will discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify limitations and propose measures to optimise the process. It will also seek to establish the value and enable the use of patient registries for regulatory decision-making.
Date
date 12/02/2024 - 13/02/2024
Venue
venue EMA and online
 
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Recent events

Methodology Working Party stakeholder interaction meeting, 7 December 2023
The virtual meeting with stakeholders was held to consolidate comments received during the public consultation on the revised Methodology Working Party (MWP) workplan. The objective of the meeting was to shape the updated MWP workplan for final endorsement at the Committee for Medicinal Products for Human Use (CHMP) preparatory and organisational matters (PROM) plenary meeting.
 
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HMA/EMA Big Data Stakeholder Forum 2023, 4 December 2023
The annual meeting was held to update participants on the delivery of big data activities under the Network Strategy to 2025. Discussions with stakeholders took place on further opportunities for big data in medicines development and regulatory decision-making. In addition, keynote speakers shared their insights on cutting-edge topics.
 
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Third Veterinary Big Data Stakeholder Forum, 23 November 2023

The event reported on the EU Veterinary Data Hub activities and the HMA/EMA Veterinary Big Data workplan, discussed use cases, future needs and upcoming challenges of big data in the veterinary regulatory domain.
 
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Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world, 20-21 November 2023

The workshop took place to discuss with stakeholders the latest developments in artificial intelligence (AI) technology, policy, and its potential applications in medicines regulation. Activities undertaken by HMA/EMA to address stakeholder priorities on AI, as well as the draft AI reflection paper were also discussed.
 
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ISSN: 2811-7778 | Catalogue Number: TC-AK-23-002-EN-N