Symposium 4: Beyond Traditional Cohorts: Within-Individual Designs for Drug Safety Research in Asia
Tracks
Track 1
| Saturday, October 31, 2026 |
| 15:30 - 17:00 |
| Lecture Theatre 3 |
Details
Within-individual study designs, including self-controlled case series, case-crossover and case-case-time-control designs, are increasingly used in pharmacoepidemiology because they can control for time-invariant confounding. However, their implementation, interpretation, transportability across databases, and regulatory acceptance remain important challenges, particularly in Asia.
This symposium will provide a practical overview of within-individual study designs for drug safety research, with emphasis on applied examples, database-specific considerations, multinational research, and regulatory and industry perspectives in Asia.
Dr Kenneth K.C. Man will introduce the principles, assumptions and interpretation of within-individual methods, and explain how these designs can address different pharmacoepidemiological questions. (15 min)
Prof Edward Chia-Cheng Lai will discuss case-crossover and case-case-time-control designs, drawing on methodological expertise and experience using Taiwanese healthcare data. His presentation will highlight the definition of case and reference windows and practical considerations for Asian electronic healthcare databases. (15 min)
Dr Andrew S.C. Yuen will discuss the use of self-controlled case series to assess drug-drug interactions, using examples from Korean and UK databases. He will compare differences in data structure, coding systems, exposure capture, outcome ascertainment and interpretation across settings. (15 min)
Dr Wallis C.Y. Lau will discuss how self-controlled and cohort study approaches can be combined to confirm, contextualise or triangulate findings, and how different designs can strengthen causal interpretation in real-world evidence generation. (15 min)
Prof Ju-Young Shin will provide an Asian regulatory and industry perspective on within-individual studies, including how these designs may support pharmacovigilance, post-authorisation safety evaluation and benefit-risk decision-making. (15 min)
The symposium will be moderated by Prof Amy Chan and Dr Adrienne Y.L. Chan. It will conclude with an 15-minute panel discussion involving all speakers, and joined by Mr. Tin Hong Wong from AstraZeneca, to reflect on the practical use, interpretation, and broader implications of within-individual designs in drug safety research.
1. To review the principles, assumptions, strengths and limitations of different within-individual designs.
2. To demonstrate how within-individual designs can be applied across Asian and international healthcare databases, including Korea, Taiwan, the UK and Hong Kong.
3. To discuss practical challenges in exposure definition, risk-window selection, database harmonisation, outcome ascertainment and interpretation across settings.
4. To examine how within-individual evidence can be complemented by cohort designs, target-trial emulation and triangulation across methods.
5. To consider regulatory and industry perspectives on the use of self-controlled designs for pharmacovigilance and real-world evidence generation in Asia.
This symposium will benefit researchers, regulators, industry scientists, clinicians, early-career researchers and students involved in pharmacoepidemiology, pharmacovigilance, real-world evidence generation or the analysis of large healthcare databases.
Speaker
A/Prof Amy HY Chan
Head Of School
The University of Auckland
Symposium Moderator
Biography
Associate Professor Amy Chan is Head of the School of Pharmacy at the University of Auckland and a clinical academic pharmacist. Her research focuses on medicines use and outcomes, pharmacoepidemiology, behavioural medicine, digital health, and respiratory health. She leads research using real-world data and digital technologies to improve medication use and healthcare delivery and has contributed to international respiratory policy and World Health Organization initiatives.
A/Prof Adrienne Chan
Aston University
Symposium Moderator
Biography
Dr Adrienne Chan is a Lecturer in Pharmacoepidemiology at Aston University. Her research focuses on the safety and effectiveness of psychiatric and neurological medicines across the life course, including medication use during pregnancy, neurodevelopmental outcomes and ADHD. She has particular expertise in multinational pharmacoepidemiology, common data models and the analysis of large-scale linked healthcare databases. She is also an Honorary Assistant Professor at the University of Hong Kong.
Prof Edward Lai
National Cheng Kung University
Symposium Presenter
Biography
Edward Lai is Professor at the School of Pharmacy and Institute of Clinical Pharmacy and Pharmaceutical Sciences, and Director of the Population Health Data Center at National Cheng Kung University. His research focuses on pharmacoepidemiology, real-world data, causal inference and international multi-database studies. He is a Fellow of the International Society for Pharmacoepidemiology and has served on the ISPE Board of Directors since 2025.
Dr. Kenneth Man
UCL
Symposium Presenter
Biography
Dr Kenneth K.C. Man is a pharmacoepidemiologist and medical statistician at UCL School of Pharmacy. His research uses large-scale routinely collected healthcare data to evaluate medication safety and effectiveness, with a particular focus on self-controlled designs and other causal inference approaches for observational data. His applied work centres on psychiatric, paediatric and perinatal pharmacoepidemiology, and he has led international multi-database studies of medicines used in children, in pregnancy and by people with mental health conditions. He chairs the CPRD Expert Review Committee and serves on the central advisory committee for CPRD.
Dr Andrew SC Yuen
Postdoc Research Fellow
UCL
Symposium Presenter
Biography
Dr Andrew Yuen is a registered pharmacist in the UK and Postdoctoral Research Fellow in Pharmacoepidemiology at UCL School of Pharmacy. His research focuses on the utilisation and safety of neuropsychiatric medicines using multiple sources of healthcare data, with particular expertise in self-controlled study designs, including self-controlled case series, case-crossover and case-case-time-control approaches. He has applied these methods across different healthcare settings and databases in the UK and South Korea to investigate medication-related safety outcomes, with a particular focus on gabapentinoids.
Dr. Wallis Lau
UCL
Symposium Presenter
Biography
Dr Wallis Lau is a Lecturer in Pharmacoepidemiology and Drug Safety at UCL School of Pharmacy. With a background in statistics and a PhD in pharmacoepidemiology, her research uses large electronic healthcare databases to investigate the safety and effectiveness of medicines. Her research interests include cardiovascular, neurological and mental health conditions, and she has extensive experience applying real-world evidence and advanced pharmacoepidemiological methods to clinically important medication-safety questions.
Prof Ju-Young Shin
Seoul National University
Symposium Presenter
Biography
Professor Ju-Young Shin is Professor at the College of Pharmacy, Seoul National University. Her research specialises in pharmacoepidemiology, pharmacovigilance and the use of real-world healthcare data to evaluate medicine safety and effectiveness. She has extensive experience conducting studies using Korea's nationwide health insurance databases and leading international multi-database collaborations. Professor Shin received her pharmacy, public health and doctoral training at Seoul National University and previously held academic positions at Sungkyunkwan University.
