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EMA - HMA-EMA Real-World Data (RWD) Catalogues Survey

11th December 2024

EMA

The European Medicines Regulatory Network and EMA have launched in February 2024 the HMA-EMA Real-World Data (RWD) Catalogues, a publicly available online resource collecting metadata information on RWD sources and studies, which replaced the ENCePP Resources Database and the EU PAS Register®. The RWD Catalogues aim to help regulators, researchers and pharmaceutical companies identify and utilise RWD to investigate the use, safety and effectiveness of medicines.
EMA’s goal is to make the Catalogues a central, comprehensive repository containing metadata information from as many data sources and studies as possible across Europe and beyond with the aim to:  

  • Increase the possibility of identifying relevant data sources as suitable sources for non-interventional studies, and promote collaboration and utilisation of the most appropriate data source(s) in such studies;
  • Enhance the visibility of available data sources, making them known to regulators, researchers, and pharmaceutical companies;
  • Allow regulators to better interpret study results based on specific data sources as part of a regulatory procedure;
  • Link the data sources to studies registered in the Catalogue of RWD studies which have utilised these data sources and therefore promote transparency in observational research.

The RWD Catalogues are a key deliverable outlined in the revised Big Data Steering Group workplan 2023-2025 and fulfil one of the ten priority recommendations set by the joint HMA-EMA Big Data Task Force, specifically focusing on “Data discoverability.” 
Following their launch in February we are interested to know about your experience with the RWD Catalogues and how we could further improve them.
We would like to invite you to fill out our survey on the RWD Catalogues by 10 January 2025.
The aim of the survey is to collect feedback on the RWD Catalogues’ usability and insights on potential improvements that could enhance the RWD Catalogues and users experience.

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