Emerging Challenges in Global Pharmacovigilance

Global pharmacovigilance has evolved rapidly, yet emerging challenges continue to reshape the field. Differences in regulatory frameworks, reporting standards, and local infrastructure create inconsistencies in adverse event reporting and data harmonization. Additionally, the increasing volume of real-world evidence, expansion into low- and middle-income markets, and the complexity of biologics and combination therapies necessitate adaptive pharmacovigilance models. Data privacy regulations such as GDPR add further complexity to cross-border data sharing. Language barriers, limited technological access, and underreporting in certain regions further hinder the global safety network. Moreover, the rise of digital health tools introduces novel sources of safety data that must be validated and incorporated into pharmacovigilance processes. There is also an urgent need for capacity-building initiatives and international collaborations to ensure equitable safety surveillance worldwide. This session delves into the multifaceted nature of these challenges, highlighting strategic solutions and innovations that can support harmonized global pharmacovigilance while protecting public health across diverse populations.

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