On November 28, the European Medicines Agency (EMA) hosted its fifth annual Big Data Stakeholder Forum. This multi-stakeholder event presents and celebrates progress of the European Regulatory network, towards its vision of data-driven regulatory decision-making. Structured around a series of keynote presentations, with interventions and comments from national regulatory agencies, patient organisations, healthcare professional bodies, industry and academia, the event brought together experts from across Europe.
Following opening remarks from Marco Greco (European Patients’ Forum) Rui Santos Ivo (Infarmed, Portugal) and Lorena Boix Alonso (Deputy Director-General, DG Sante at the European Commission), the first session focused on the delivery of the Heads of Medicines Agencies (HMA)/EMA big data priority recommendations, hearing from stakeholders on gaps and priorities. These recommendations include the delivery of a platform for accessing and analysing “real-world data” (data derived from “real-world” sources such as electronic patient records or insurance records) and developing network skills for Big Data.
The second session continued on a similar theme, exploring the critical role of evidence generation in enhancing regulatory decision-making and the key progress being made for the use of real-world data and clinical trial raw data. Bruno Sepodes, who is the current Chair of the Committee for Medicinal Products for Human Use, outlined the vision for using different data sources to generate clinical evidence, underlining the core role for the patient voice to provide guidance at each step along the regulatory decision-making path.
Our Director for Research, Angela Bradshaw, participated in a session entitled “Evidence Generation to Advance Regulatory Excellence: Preparing for Tomorrow”, which explored novel sources of real-world data to support regulatory assessment. Experts from the EMA and Italian national regulatory agency showed how mHealth and social media data could be useful to provide insights on “real-world” outcomes that are valued by patients and their families. In her intervention, Angela highlighted the need to ensure inclusion when identifying and using novel data sources, stressing the need to consider challenges relating to digital inclusion that may inadvertently exclude groups that do not use social media or mHealth applications.
The final session, “Unlocking the Value of Data within the European Medicines Regulatory Network Strategy” explored how to maximise the generation of evidence, and the use and exchange of data to support regulatory decision-making. For this, a robust network data strategy is essential to ensure the network data assets are appropriately managed and have a high level of interoperability, standardisation and quality. Peter Arlett, co-Chair of the EMA Big Data Steering Group, drew the Forum to a close, thanking all attendees for their active participation.
https://www.ema.europa.eu/en/events/fifth-ema-hma-big-data-stakeholder-…
