"Big Data Highlights" Newsletter Issues

Joint HMA-EMA Big Data Steering Group workplan (27/06/2023)

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.

Now available: HMA-EMA catalogues of real-world data sources and studies (19/03/2024)

The new electronic catalogues were launched on 15 February 2024 and have replaced the former ENCePP Resource Database and EU PAS Register. These enhanced, publicly available catalogues provide a valuable resource for medicines regulators and stakeholders who need to use data for medicines regulation.

The capacity of DARWIN EU® for conducting RWD studies continues to expand (19/03/2024)

With additional data partners in the network DARWIN EU® continues to increase its capacity for real-world data (RWD) studies. This follows the completion of its two year-establishment phase that started when the Coordination Centre was set up in February 2022.

Clinical trials ‘raw data’ pilot: last places open to participate (19/03/2024)

The pilot, which aims to include a total of ten regulatory procedures, has recently selected its sixth and seventh procedures. These two procedures are initial marketing authorisation applications in the fields of oncology and gastroenterology.

Scientific Explorer – AI enabled knowledge mining solution for EU regulators (19/03/2024)

Scientific Explorer, launched in March 2024 and driven by AI, aids regulatory network staff in their daily work by enabling easy, focused, and precise searching of regulatory and scientific information. The first release is dedicated to scientific advice procedures for human medicines. EU network staff are invited to attend training sessions to learn more about Scientific Explorer.

Big Data Steering Group annual report 2023 (19/03/2024)

The report provides a summary of the key activities and accomplishments of the Big Data Steering Group during 2023 as it works towards a more data-driven approach to medicine regulation.

Midterm report on 2025 network strategy (19/03/2024)

The midterm report offers a snapshot of the achievements made from January 2021 to June 2023. It reviews the original goals and objectives as well as the actions to achieve them.

Major update of the SME user guide (19/03/2024)

The new release includes updates to reflect changes in the EU’s legal and regulatory framework for the development and authorisation of medicines for human and veterinary use.

EU Network training webinar: use of Scientific Explorer in scientific advice regulatory procedures (03/04/2024)

EMA scientific committee members, NCAs assessors, and EMA staff who work with scientific advice procedures or marketing authorisation procedures are invited to attend this webinar. The purpose of the webinar is to demonstrate how Scientific Explorer, an AI-enabled knowledge mining tool, can assist in finding relevant information more efficiently and effectively.

Joint HMA-EMA Big Data Steering Group workshop on RWE methods - 14 June 2024 (14/06/2024)

SAVE THE DATE!

Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data sources and studies: 4 March 2024 (19/03/2024)

This event was held to provide an overview of the newly launched catalogues highlighting their benefits and significance in regulatory practices. In addition, the event included a demonstration showcasing the key features of the Catalogues.

Multi-stakeholder workshop on data quality framework for Adverse Drug Reaction reporting: 1 March 2024 (19/03/2024)

The workshop was held to gather input from stakeholders involved in Adverse Drug Reaction (ADR) reporting. The aim of this workshop was to bring together experts in the field, build on their extensive experience, and exchange knowledge related to improving ADR data quality.

Multistakeholder workshop on Patient Registries: 12-13 February 2024 (19/03/2024)

The workshop took place to discuss the EMA qualification procedure for patient registries with the aim to clarify the benefits, identify limitations and propose measures to optimise the process. The meeting also considered contexts of use for which registry data are ‘fit for purpose’ including tools to support data discoverability and assessment.

ACT EU Clinical Trials Analytics Workshop, 25-26 January 2024 (19/03/2024)

The workshop was held to explore potential use cases for accessing clinical trials data and performing data analysis. In addition, the meeting sought input on identifying evidence gaps within the EU clinical trials environment. Participants were also informed about international efforts towards standardising clinical trials data and clinical trial analytics attached to the ACT EU multi-stakeholder platform.

Publication of Artificial Intelligence workplan to guide use of AI in medicines regulation (13/12/2023)

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.

Data Quality Framework sets the standard for health data (13/12/2023)

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.

Get ready for the launch of data sources and studies catalogues in February 2024! (13/12/2023)

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.

DARWIN EU® continues to scale up in its second year of establishment (14/12/2023)

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.

Real-world evidence and data sources training opportunities for regulatory network (14/12/2023)

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.

Webinar on the Union Product Database Data Quality Framework, 11 January 2024 (11/01/2024)

National competent authorities (NCAs) are invited to attend this session for a progress report on the UPD Data Quality Framework

ACT EU Clinical Trials Analytics Workshop, 25-26 January 2024 (25/01/2024)

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.

HMA/EMA Multistakeholder Workshop on Patient Registries, 12-13 February 2024 (12/02/2024)

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.

Methodology Working Party stakeholder interaction meeting, 7 December 2023 (14/12/2023)

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.

HMA/EMA Big Data Stakeholder Forum 2023, 4 December 2023 (14/12/2023)

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.

Third Veterinary Big Data Stakeholder Forum, 23 November 2023 (14/12/2023)

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.

Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world, 20-21 November 2023 (14/12/2023)

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.

Halfway point of clinical trials ‘raw data’ pilot – applicants can still register to participate (27/09/2023)

The proof-of-concept pilot has selected its fifth regulatory procedure and reached the halfway point in its journey to test the role of analysis of clinical trials ‘raw data’ submitted to EMA in electronic structured format. The last selected procedure relates to an initial marketing authorisation application in gastroenterology.

HMA/EMA Big Data Steering Group updates its workplan to accelerate transformation to data-driven medicines regulation (27/09/2023)

The HMA/EMA Big Data Steering Group workplan has been enhanced including work on national regulatory use cases for real-world evidence (RWE), intensified work on artificial intelligence (AI) and public consultation on patient experience data (PED).

Watch this space: launch of EMA-HMA catalogues of data sources and non-interventional studies in early 2024 (27/09/2023)

The European Medicines Regulatory Network is developing two new public catalogues, one for real-world data sources and one for non-interventional studies. These catalogues will replace and enhance the current ENCePP Resources Database and the EU PAS Register at the beginning of next year.

DARWIN EU: Data partners expression of interest deadline - 31 October 2023 (27/09/2023)

EMA is looking for new data partners to collaborate with DARWIN EU®. If your public or private organisation has access to real-world healthcare data, you might be interested in becoming a new data partner in DARWIN EU®. The data could contribute to studies that generate real-world evidence supporting scientific evaluation and regulatory decision-making on medicines in the EU.

Open consultation: draft reflection paper on the use of artificial intelligence (AI) in medicines lifecycle (27/09/2023)

The European Medicines Regulatory Network is inviting interested stakeholders to comment on the AI draft reflection paper. This paper outlines current views on the use of AI in the lifecycle of human and veterinary medicines. The public consultation is open until 31 December 2023.

Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis (27/09/2023)

EMA is funding a research project entitled “Big Data in Veterinary Medicines Regulation: A Data Landscape Analysis”.

Veterinary Data Hub established (27/09/2023)

Established in June 2023, the Veterinary Data Hub brings together a multidisciplinary team of Network experts from Belgium, France, Germany, Portugal, Spain and Sweden. This group of experts collaboratively engages in advancing the EU Veterinary Big Data strategy and contributes to the planned activities within this framework.

Joint HMA/EMA AI workshop – Smart regulation in a rapidly evolving world (20/11/2023)

The objectives of this workshop are to engage stakeholders with keynote speakers on AI developments in technology, policy and potential applications in medicines regulation, inform on the HMA/EMA activities to deliver the stakeholder’s priorities on AI and discuss with stakeholders and experts the draft AI reflection paper.

Third Veterinary Big Data Stakeholder Forum (23/11/2023)

The event aims to report on the EU Veterinary Data Hub activities and the HMA/EMA Veterinary Big Data workplan. Furthermore, it will resume the discussion on the identified use cases, collect inputs, and learn from existing experiences from stakeholders’ experts as well as discuss upcoming challenges and future needs of big data in the veterinary regulatory domain.

Biannual Big Data Steering Group and industry stakeholders meeting (27/11/2023)

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.

HMA/EMA Big Data Stakeholder Forum 2023 (04/12/2023)

The forum aims to inform and strengthen collaboration with partners and stakeholders on the delivery of big data activities of the Network Strategy to 2025, discuss further big data opportunities in medicines development and regulatory decision making as well as engage participants with keynotes speakers on cutting-edge topics.

Review of experience with real-world data studies in medicines assessment (21/06/2023)

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.

DARWIN EU® open call for interest for new data partners (08/06/2023)

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? (08/06/2023)

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 (09/06/2023)

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! (07/06/2023)

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 (09/06/2023)

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 (20/06/2023)

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”.

Multi-stakeholder workshop on real-world data quality and experience in use of real-world evidence for regulatory decision-making: 26-27 June 2023 (26/06/2023)

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 (28/06/2023)

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 (28/06/2023)

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