Latest perspectives on PV data access and integration

The latest research from the DSRU’s International Working Group on New Developments in Pharmacovigilance has been published by Drug Safety. This work draws on the insights of nine experts who participated in an international focus group examining current challenges and opportunities related to data access and data integration in pharmacovigilance. Participants represented a range of sectors, including regulatory agencies, academia, industry, and pharmacovigilance centres.

The focus group reflected on how drug safety monitoring is evolving, particularly considering the expanding range of data sources now available beyond traditional clinical trials and spontaneous reporting systems. Discussions explored both the potential benefits and inherent complexities of incorporating real-world data into pharmacovigilance practice.

Key challenges identified included issues surrounding data quality, standardisation, interoperability, and governance when accessing and integrating data for pharmacovigilance purposes. The group also considered emerging analytical approaches and digital tools, recognising their potential value while acknowledging that their role in routine pharmacovigilance is still developing.

Overall, the paper presents a range of perspectives on how pharmacovigilance may adapt to an increasingly data-rich environment in future. It highlights the importance of collaboration, transparency, and continued methodological development to support the ongoing advancement of pharmacovigilance practice.

The full paper is available open access here: https://link.springer.com/article/10.1007/s40264-025-01646-2