Symposium 5: Evidence generation using multi-jurisdictional real-world data throughout the drug life cycle
Tracks
Track 1
| Sunday, November 23, 2025 |
| 11:15 - 12:45 |
Details
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.
Speaker
Prof Simon Bell
Professor
Centre for Medicine Use and Safety, Monash University
Symposium Moderator
Biography
Professor Simon Bell is Director of Monash University’s Centre for Medicine Use and Safety. He is also Adjunct Professor of Geriatric Pharmacotherapy, Faculty of Health Sciences, University of Eastern Finland. Professor Bell has extensive experience conducting research on patterns and outcomes of medication use in older people. Professor Bell was an Australian National Health and Medical Research Council (NHMRC) Dementia Leadership Fellow 2017-2022. He was Chief Investigator of the NHMRC Centre of Research Excellence in Frailty and Healthy Ageing and NHMRC Cognitive Decline Partnership Centre. He is Chair of Australia’s Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care; and Co-Chair of the new 2026 Australian Dementia Guidelines. He is also Associate Editor of the Journal of Pharmacy Practice and Research. He has supervised 18 PhD students to completion in Australia and Finland. He co-founded the Neurological and Mental Health Global Epidemiology Network (NeuroGEN).
Prof Siyan Zhan
Dean School of Public Health
School of Public Health, Peking University
Symposium Moderator
Biography
Professor Zhan graduated from Beijing Medical University in 1986, and obtained postgraduate training in the Chinese University of Hong Kong. Her major is Epidemiology, especially pharmacoepidemiology.
Prof. Zhan is the Dean, School of Public Health, Peking University, Director, Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Director, Center for Clinical Epidemiology, Peking University Third Hospital. She is the Chairman of China Epidemiology Association, Editor-in-Chief, Chinese Journal of Pharmacoepidemiology, and Deputy Editor-in-Chief, Chinese Journal of Epidemiology.
As a principal investigator, Prof. Zhan has conducted many postmarketing research projects supported by the national natural science foundation of China (NSFC), CFDA and global fund. She has published more than 100 papers in pharmcoepidemiology field. She is also the editor-in-chief, the current Textbook of Epidemiology, Textbook of Clinical Epidemiology and Textbook of Pharmacoepidemiology in China.
Dr. Celine Chui
Assistant Professor
School of Nursing, The University of Hong Kong
Symposium Presenter
Biography
Professor Chui is an Assistant Professor at the School of Nursing at HKU. She obtained her PhD degree from the Department of Pharmacology and Pharmacy at HKU. She was an academic scholar at the London School of Hygiene and Tropical Medicines in United Kingdom and currently a visiting scholar at the St George’s University of London. She received multiple award and recognitions including World’s top 2% most cited scientists by Stanford University, Li Ka Shing Faculty of Medicine Outstanding Research Output Award, Li Ka Shing Faculty of Medicine Knowledge Exchange (KE) Award, and the John Snow Award from the International Society on Pharmacoepidemiology. She has published more than 130 articles in peer-reviewed journals such as The Lancet Infectious Disease, JAMA Internal Medicine, BMJ, Journal of the American College of Cardiology, and Neurology.
Her research interest is utilizing real-world evidence to enhance population health outcomes through knowledge translation and dissemination science. She is the principal investigator or research lead of several funded competitive grants including Collaborative Research Fund, Health and Medical Research Fund Fellowship / Commission, Early Career Scheme, General Research Fund and Innovation and Technology Commission Partnership Research Programme. Professor Chui is also one of the lead researchers in the COVID-19 Vaccines Adverse Events Response and Evaluation (CARE) Programme, a comprehensive surveillance programme to monitor known and potential adverse events of COVID-19 vaccines. She is the current chair and convener of NeuroGEN (Neurological and Mental Health Global Epidemiology Network).
She developed an AI-powered risk prediction tool for assessing the risk of cardiovascular events among the Chinese population, named Personalised Cardiovascular Disease Risk Assessment for Chinese (P-CARDIAC). It demonstrated outstanding performance following validation with comprehensive data from Hong Kong. She is now leading an on-going implementation study of P-CARDIAC which will have a significant impact on improvements in patient outcomes and a reduction in healthcare burden.
Dr Ching-Lung Cheung
Associate Professor
Department of Pharmacology and Pharmacy, The University of Hong Kong
Symposium Presenter
Biography
Professor Ching-Lung Cheung serves as the Director of the Real-World Study and Application Centre (RWSAC), established by the HKSAR government, and is an Associate Professor at the University of Hong Kong. His research focuses on the epidemiology and precision medicine of osteoporosis and related clinical conditions, encompassing cell and animal model studies, real-world data analysis, genetic epidemiology, and clinical trials. He has authored over 180 peer-reviewed publications in leading journals, including Lancet, JAMA, and Nature Genetics.
Dr Bin Hong
Sungkyunkwan University
Symposium Presenter
Biography
Dr. Bin Hong is a pharmacoepidemiologist specializing in the use of big data to address unexplored clinical questions about drug safety and effectiveness. His research primarily focuses on evaluating treatment strategies for patients with cardiometabolic diseases using real-world data. He applies appropriate and advanced statistical methods such as propensity score methods and target trial emulation to support clinical decision-making and bridge evidence gaps.
Prof Zanfina Ademi
Professor
Centre for Medicine Use and Safety, Monash University
Symposium Presenter
Biography
Professor Zanfina Ademi leads the Health Economics and Policy Evaluation Research (HEPER) Group at Monash University. Her research aims to improve health outcomes and reduce inequities by generating high-quality economic evidence to support decision-making. She has developed and applied innovative methods, including Productivity-Adjusted Life Years (PALY) and the use of Mendelian randomisation as real-world evidence to inform health policy. Her work spans prevention, population genomic screening, and disease management, with funding from national and international sources. She has held academic positions in Australia, Finland, and Switzerland, and her research has supported cost-effectiveness decisions across global healthcare systems. Zanfina serves on several influential committees, including the Economics Sub-Committee of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC).
Mr George SQ Tan
Research Fellow
Centre for Medicine Use and Safety, Monash University
Symposium Presenter
Biography
Dr. George Tan is a Research Fellow in Pharmacoepidemiology and Real-world Evidence at the Centre for Medicine Use and Safety, Monash University. His research aims to generate real-world evidence on medication use patterns and outcomes, focusing on diabetes, cardiovascular diseases, and in older adults. His PhD investigated how pharmacoepidemiologic methods can be utilised to generate and validate drug repurposing hypotheses. George serves as the Deputy Chair of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) Pharmacoepidemiology Special Interest Group. He also teaches into Evidence-based Practice, Medication Safety, and other topics as an Assistant Lecturer at the Faculty of Pharmacy and Pharmaceutical Sciences. George is a practising pharmacist, with experience in both community and hospital pharmacy.
Prof Olaf Klungel
Professor
Utrecht University
Symposium Presenter
Biography
Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology, and scientific director of the Utrecht Institute of Pharmceutical Sciences (UIPS) at Utrecht University. He was trained as a pharmacist and epidemiologist. His main research area is the development, improvement and evaluation of innovative methods of observational drug research. Main applications are in the post-registration phase of drug development. Prof. Klungel is member of the Methodology Working Party of the European Medicines Agency. past-elected member of the Steering Committee of ENCePP, past President of the International Society of Pharmacoepidemiology (ICPE) and is PI of the EU Pharmacoepidemiology & Pharmacovigilance Research Network (EU PE&PV). He is Editor of the European Office of Pharmacoepidemiology & Drug Safety. Prof. Klungel teaches pharmacoepidemiology and pharmacotherapy to medical and pharmacy students. He is (co-)author of over 350 papers in peer reviewed journals, book chapters and research reports.
