- Examined the megadata landscape from a regulatory perspective and identified opportunities to improve the functioning of drug regulation;
- Conducted online surveys of national regulatory agencies and the pharmaceutical industry on perspectives, expertise, and challenges, highlighting challenges and the current state of expertise in the regulatory network.
- Provide a sustainable platform for accessing and analyzing health data from across the EU (Data Analysis and Real World Query Network -DARWIN);
- Establish a European framework for data quality and representativeness;
- Activate data discovery capability;
- Develop EU network competencies in the area of big data;
- Strengthen EU network processes for megadata submissions;
- Strengthen the EU network's capacity to analyze big data;
- Modernize expert advisory delivery;
- Ensure data is managed and analyzed within a secure and ethical governance framework;
- Collaborate with international initiatives on big data;
- Create an EU "stakeholder forum" on megadata implementation.
The Big Data Steering Group, HMA/EMA steering group
The joint HMA/EMA Big Data Steering Group advises EMA and HMA on prioritizing and planning actions to implement these ten recommendations. Co-chaired by Jesper Kjær, Director of the Data Analysis Center at the Danish Medicines Agency, and Peter Arlett, Head of Data Analysis and Methods at EMA, it began its work in May 2022. Each year, it revises the work plan to cover any new emerging topics, so the last update was in July 2022.The Third Work Plan 2022-2025
The joint HMA-EMA Big Data 2022-2025 work plan follows the key recommendations and includes primarily human drug-related activities. However, the scope of some activities covers veterinary aspects and a separate section of the work plan is entirely dedicated to veterinary drugs. However, its implementation will be flexible and some actions may be rescheduled, as the European Medicines Regulatory Network must prioritize the unprecedented public health challenge of the Covid-19 pandemic. It presents deliverables and timelines, including for the following areas:- Data Analysis and Real World Interrogation Network (DARWIN EU), the EMA's data and services network in Europe for better use of real world evidence in drug evaluation: the work plan calls for more than 100 DARWIN EU studies per year by 2025 ;
- Data quality: a data quality framework for the EU regulatory network is to be delivered by the end of 2022, following analysis and exchanges on data quality with a wide range of stakeholders, including patients, healthcare professionals, regulators, the pharmaceutical industry and academia;
- Data discovery: the publication of a best practice guide on real-world metadata and a public catalog of European real-world data are planned, as well as the development of analysis tools for better information retrieval and the development of standardized clinical trials;
- EU network skills: the work plan includes the provision of training on biostatistics, pharmacoepidemiology and data science for regulators with targeted access for patients, healthcare professionals and academics.
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