Symposia Overviews

The use of real-world data (RWD) to generate real-world evidence (RWE) for regulatory, health technology assessment (HTA), and clinical decision-making has grown substantially in recent years. RWE can complement traditional clinical trial data, offering insights into the safety, effectiveness, and cost-effectiveness of drugs in routine clinical settings.

Despite this progress, the integration of RWE into formal decision-making processes remains inconsistent. Regulatory agencies, HTA bodies, and clinical associations around the world have issued frameworks and guidelines to support the use of RWE. However, the acceptance, interpretation, and practical application of RWE still vary across jurisdictions and stakeholders.

Multi-jurisdictional RWD studies are increasingly recognised for their potential to improve the generalisability and applicability of evidence across geographic regions. These studies are particularly valuable when regulatory, HTA, or clinical decisions must be made that affect diverse populations or span multiple regions. The Neurological and Mental Health Global Epidemiology Network (NeuroGEN) was established in 2018 to provide a platform for institutes to conduct multi-jurisdictional research, with a focus on neurodegenerative diseases and psychiatric disorders, but has recently extended to other disease areas.

This symposium will showcase case studies conducted by members of NeuroGEN, highlighting how multi-jurisdictional RWD studies have been used across different stages of the drug life-cycle – from regulatory, HTA, to clinical decision-making. Presentations will include collaborative work within Asia, Europe, and Australasia.

The symposium will commence with a short 10-minute introduction by the current Chair of NeuroGEN on recent developments in multi-jurisdictional RWD/RWE studies, highlighting both opportunities and challenges in the field. This introduction will also include an overview of NeuroGEN, its scope, recent activities, and future directions. Following the introduction, five 10-minute presentations will showcase case studies of how multi-jurisdictional RWD is being applied to inform different stages of the drug life cycle in Asia, Europe, and Australasia. The symposium will conclude with a 30-minute panel discussion, involving all speakers.

This topic is highly relevant to ISPE’s membership, particularly in Asia, where regulatory acceptance of RWE is accelerating. Recent updates in Japan (2016), South Korea (2025), and mainland China reflect a growing willingness to incorporate RWE into supporting indication expansions and post-marketing requirements. As RWD infrastructure across the region improves in both coverage and quality, Asia is increasingly positioned to play a central role in global RWE generation.

While multi-jurisdictional RWE studies are well-established in Europe (e.g., EU PE&PV, DARWIN EU) and in the US (e.g., FDA Sentinel Initiative), such collaborative models are still in development in Asia. NeuroGEN can help bridge this gap by enabling high-quality, cross-border research on drug use and outcomes with global relevance. This symposium directly supports ISPE’s mission to advance pharmacoepidemiology through global collaboration, providing a timely opportunity to highlight Asia’s growing leadership in the field.

Post-marketing surveillance (PMS) practices in Asia are evolving to integrate real-world data/evidence (RWD/RWE) as a part of decision making. Japan’s Good PMS practice now allows drug developers to conduct RWE studies to meet regulatory requirements, while South Korea is transitioning from the traditional “Use-Result Surveillance” to a more evidence-driven approach using RWD, set to take effect in 2025. In contrast, Europe has long integrated RWD into PMS through post-authorisation safety studies (PASS). To ensure consistency in global drug safety evaluation, it is essential for regulatory frameworks in Asia to align with these well-established standards.

This symposium will commence with a brief introduction of the learning objectives and contents by the session moderators, followed by four presentations discussing the regulatory standards on PMS practice using RWD from different regions and concluding with a panel discussion.

This symposium will explore regulatory requirements for PMS using RWD across different regions, focusing on the scientific rigor of pharmacoepidemiologic research to meet these standards. Key discussions will include study design considerations, comparator group selection, and methodological approaches to addressing confounding and bias that are accepted by the regulatory bodies.

For ISPE members in the Asian region—many of whom are actively engaged in pharmacoepidemiologic research or regulatory science—this topic is particularly relevant as it provides practical insights into evolving regulatory expectations, methodological rigor, and international alignment in implementing RWD in PMS.