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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.
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Calling all data holders: register your data source to help unlock the power of real-world data
Do you hold or know someone who holds a data source? Join us in unlocking the potential of real-world data (RWD) by registering your data source in the Catalogue of RWD sources or encouraging others to do so.
EMA has published a summary guide for EU regulators and decision-makers on how the Agency can support the delivery of regulator lead real-world evidence to aid decision-making. The guide includes descriptions of the available types of real-world data studies, optimal resources for addressing research questions and details about the process for requesting these studies.
Public consultation on real-world evidence reflection paper
A reflection paper on non-interventional studies that use real-world data to generate real-world evidence for regulatory purposes is available for public consultation. All interested partners and stakeholders are invited to provide feedback by 31 August 2024.
International collaboration on real-world evidence
ICH adopted a reflection paper to further enable real-world evidence integration into regulatory decision-making across the world. Furthermore, the ICH M14 draft guideline on non-interventional pharmacoepidemiological studies for safety assessment of medicines is open for public consultation until 30 August 2024.
Report on patient registries workshop 12-13 February 2024
The report on the workshop, which focused on the registries use for regulatory purposes, is now available. It summarises the discussions and highlights recommendations to optimise the qualification of novel methodologies for patient registries. The report also identifies ways to improve data quality, discoverability and assess the fitness for purpose of data sources for regulatory decisions.
The ACT EU workshop on 25-26 January 2024 highlighted a collective ambition to improve the use of data about clinical trials, with a multi-stakeholder approach to identify research priorities. This will speed up the development of an analytics ecosystem that maximises health benefits for EU citizens. A report summarising the discussion has been published on the ACT EU website.
The workshop aims to identify priority areas for regulatory action in pharmacogenomics, discuss how regulators can promote genomics in healthcare systems, leverage genomic data linked to real-world sources and increase the regulatory impact of EU-funded projects in personalised medicine.
Joint HMA-EMA Big Data Steering Group workshop on RWE methods - 14 June 2024
A workshop was held to gather input from stakeholders and experts on the draft RWE reflection paper, as well as priorities for further regulatory guidance development and collaboration. The aim was also to engage participants in discussions around RWE methods in regulatory decision making.
Methodology Working Party Interested Parties meeting - 7 June 2024
The regular Interested Parties meeting provides stakeholders with a platform to share their reflections on relevant methodological topics and engage in discussions with members of the Methodology Working Party (MWP) and the Methodology European Specialised Expert Community (Methodology ESEC).
Biannual Big Data Steering Group and industry stakeholders meeting - 23 May 2024
Objectives of this meeting are to have an open dialogue and hear industry’s perspective on selected big data topics and to inform industry stakeholders on key progress concerning the BDSG workplan delivery.
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