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

Review of experience with real-world data studies in medicines assessment

Report published on experience gained in conducting real-world data studies as part of the EU Network’s efforts to enable the use of real-world evidence in regulatory decision making.

News

DARWIN EU® open call for interest for new data partners

The open call for expression of interest to become a potential data partner in DARWIN EU®, launched in March 2023, remains continuously open. To date, the call generated sixty-six (66) responses from eighteen (18) countries including several multi-national data networks. Interested data partners are invited to visit the DARWIN EU® website for further information including FAQs.

Interested to be part of a pilot assessing the benefits of access to clinical trials raw data?

The pilot continues to welcome expressions of interest to participate from applicants or marketing authorisation holders (MAHs) that are planning to submit a marketing authorisation application or post-authorisation application to EMA.

Watch this space - open consultation on AI use in medicines regulation to be launched soon

A draft CHMP/CVMP reflection paper on the use of artificial intelligence and machine learning in the medicinal product lifecycle will soon be published. It will provide an opportunity to stakeholders to contribute to shaping AI’s future use in medicines regulation.

EU Veterinary Big Data: we have a plan!

The discussions around big data in the veterinary domain are moving from vision to action following endorsement of the EU Veterinary Big Data workplan to 2025 by the Heads of Medicines Agencies in May 2023.

Revised mandates of the key bodies governing data for medicines regulators

HMA and EMA Management Board recently endorsed revised mandates of the two main data governance bodies of the European medicines regulatory network - the Network Data Board and the Big Data Steering Group. The revisions reflect evolution to the mandates of these bodies to clarify their scope, division of responsibilities, composition and stakeholder engagement models.

ICH progresses a new reflection paper on real-world evidence

Building on the 2022 ICMRA workshop hosted by EMA, in June 2023 the ICH Assembly decided to launch a public consultation on a new paper “International Harmonisation of RWE Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using RWD, with a Focus on Effectiveness of Medicines”.

Recent events

Multi-stakeholder workshop on real-world data quality and experience in use of real-world evidence for regulatory decision-making: 26-27 June 2023

The workshop with stakeholders was held to address real world data quality linked to the EU Data Quality Framework as well as recent use of real world evidence in the regulatory decision making.

Biannual Big Data Steering Group and industry stakeholders meeting: 26 May 2023

The most recent meeting was held in May 2023 to continue the dialogue and inform industry stakeholders on key progress concerning the BDSG workplan delivery.

Multi-stakeholder workshop on qualification of novel methodologies: 17-18 April 2023

A multi-stakeholder workshop was held to explore the scope, process and outcomes of the qualification of novel methodologies platform.

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ISSN: 2811-7778 | Catalogue Number: TC-AK-23-001-EN-Q