The vision on Big Data is a strengthened regulatory system that can efficiently integrate data analysis into its assessment processes to improve decision making. Knowing when and how to have confidence in novel technologies and the evidence generated from Big Data will benefit public health by accelerating medicines development, improving treatment outcomes and facilitating earlier patient access to new treatments.
The 4th joint HMA-EMA Big Data Steering Group (BDSG) workplan was adopted in June 2023 and covers activities until 2025.
This EMA/HMA document introduces each topic and outlines key deliverables. The plan was informed by stakeholder and expert consultation and is structured in line with the key recommendations of the Big Data Task Force (see Annex I).
Read in full HERE