Big Data Highlights

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.

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.

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.

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.

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.

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.

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.

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.

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 ...