The latest advances in the healthcare sector are represented by the growing ability to record massive amounts of health data, including electronic health records, laboratory data, patient-reported outcomes, as well as data from registries and clinical trials and studies. This kind of Big Data provides researchers with new tools to meet patients’ needs. The rapidly changing data landscape requires a change in data access, management and analysis in order to keep pace with the rapid advances in science and technology.

Challenges and opportunities posed by big data in medicine will be also discussed during the Session 3 – Special insights on pharmaceutical R&D plans and rules in the framework of the pharmaceutical system reform of the XIII Foresight Training Course organised by Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus that will be held online on 23 October 2020. If you wish to discover more about this interesting topic, you can register to the event here.

Fondazione Benzi is actively involved in the sector of data science and information technology and promotes the secondary use of data especially those coming from vulnerable populations like children aiming to decrease the number of clinical trials on these populations.

For this reason Fondazione Benzi follows with interest the work done at the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) that have recently shared with the community the workplan developed by the Big Data Steering Group (BDSG) which sets actions to be delivered in 2020-21.

The BDSG was established in February 2020 to advise the EMA Management Board and HMA on implementing the ten priority recommendations for regulators to evolve their approach to data use and evidence generation, published by the HMA-EMA joint Big Data Task Force in January 2020.

The workplan, starting from the ten recommendations to unlock the potential of big data for public health in Europe, aims to increase the utility of big data in regulation from the quality of data through study methods to assessment and decision-making.

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