Building on the previous work of the Big Data Steering Group over the last 5 years, this annual event – coordinated by the Network Data Steering Group – offers an opportunity to engage with regulators...
The EMA recently published the European medicines regulatory network Data Strategy – Increasing the value of data for the benefit of public and animal health. This strategy sets out the agreed European medicines regulatory network...
The Commission has published 11 webinars exploring Europe’s journey toward connected and secure digital healthcare systems, through the eHealth Network, MyHealth@EU and the eHealth Network Guidelines. Each video offers expert insights on how Member States collaborate to...
Building on the previous work of the Big Data Steering Group over the last 5 years, this annual event – coordinated by the Network Data Steering Group – offers an opportunity to engage with regulators...
EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan “Data and AI in medicines regulation to 2028”. It sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health...
The Competent Authorities Community of Practice held their annual meeting on 12-14 February 2025 in Malta. Read the news announcement and the summary report published by Directorate-General for Health and Food Safety on 25 June...
This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes. The scope of this reflection paper is the design, conduct and analysis of...
The European Health Data Space (EHDS) will empower patients by granting new rights over their health data and enhancing data exchanges for better healthcare delivery. This session dived into the requirements for electronic health records systems...
The Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. The Regulation is an important milestone in the EU’s efforts to build a secure and efficient digital...
This document provides answers to frequently asked questions regarding the European Health Data Space (EHDS) Regulation 2025/327. This is a living document that may be updated in the future. It complements other communications products related...
