Symposium 6: Harmonizing Post-Marketing Safety Evaluation Using RWD Across Regions
Tracks
Track 2
| Sunday, November 23, 2025 |
| 11:15 - 12:45 |
Details
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.
Speaker
Dr Yongjing Zhang
Senior Director
Office of the Chief Medical Officer, Johnson & Johnson
Symposium Moderator
Biography
Dr. Zhang has been working on Real-World research in the pharmaceutical and medical device industry for over 15 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological research, and advancing Real-World Evidence guided by the value of clinical practice. He leads a team in establishing database framework and scientific research collaboration in multiple countries in the Asia-Pacific region, providing scientific consultation and training on Real-World research, and conducting cross-national Real-World studies in multiple therapeutic areas to support new indication expansion, pre- and post-market regulatory requirements, evaluation for drug safety and rational drug use in scientific management throughout the entire product lifecycle. At present, he has more than 25 scientific papers and over 60 conference abstracts published in international academic journals and conferences, which have been widely recognized by academic and regulatory institutions.
Dr. Suzu Chia-Hsien Chang
Senior Manager
Center for Observational Research, Amgen
Symposium Moderator
Biography
Dr. Chang is deeply committed to advancing real-world evidence (RWE) generation and has led research using real-world data to produce reliable evidence on specific populations. Her work has contributed to drug development and informed clinical practice across cardio-metabolic disease, inflammation, and oncology. With broad experience in both academia and industry, Dr. Chang is dedicated to collaborating with scientists worldwide to drive innovation, strengthen evidence-based decision-making, and improve patient outcomes.
Dr Ko Nakajo
Director
Office of the Chief Medical Officer, Johnson & Johnson
Symposium Presenter
Biography
Ko Nakajo is an epidemiologist and medical professional with extensive experience in
pharmaco-epidemiology, medical affairs, and drug development. Currently, he is director of Global Epidemiology APAC, Johnson & Johnson Innovative Medicine, leading post-marketing safety strategies and research initiatives in Japan. He previously held roles at Eli Lilly and Sanofi Japan, managing medical teams and clinical projects. Ko holds M.D and Ph.D. in Epidemiology and is committed to advancing evidence generation and safety assessment to support innovative therapies.
Prof Ju-Young Shin
Professor
School of Pharmacy, Sungkyunkwan University
Symposium Presenter
Biography
Dr. Ju-Young (Judy) Shin is a Professor at the School of Pharmacy, Sungkyunkwan University (SKKU), and Director of the Department of Biohealth Regulatory Science. She is an internationally recognized pharmacoepidemiologist with extensive expertise in real-world data analytics, drug safety, and regulatory science. Dr. Shin has led multiple large-scale projects funded by the Ministry of Food and Drug Safety of Korea, advancing evidence generation for post-marketing safety surveillance and innovative study designs such as external control arms. She has served on national and international advisory committees and has published widely in top journals, contributing to the harmonization of regulatory science across Asia, North America, and Europe. Dr. Shin is also committed to training the next generation of pharmacoepidemiologists and regulatory scientists through graduate education and global collaborations.
Dr Jeff Lange
Director
Center for Observational Research, Amgen
Symposium Presenter
Biography
Dr. Jeff Lange is an epidemiologist with over 25 years of experience applying real-world evidence to support health policy, drug development, and regulatory decision-making in both public and private sectors. He earned his PhD from the University of Iowa and is an Honorary Assistant Professor in the Department of Pharmacology and Pharmacy at the University of Hong Kong. Dr. Lange has worked at Amgen since 2011 and, after relocating to Asia in 2019, has collaborated with research and academic teams across the region, using epidemiology to study geographic differences in disease and standards of care to inform clinical trial design and interpretation, and applying pharmacoepidemiology to evaluate the benefits and risks of medicines in regional clinical practice.
Prof Marie L De Bruin
Professor
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Symposium Presenter
Biography
Marie Louise (Marieke) De Bruin, professor in Drug Regulatory Science at Utrecht University, the Netherlands and scientific director of the Utrecht Centre for Pharmaceutical Policy and Regulation was trained as a pharmacist (Utrecht University) and epidemiologist (Erasmus University Rotterdam) and hold a PhD in pharmacoepidemiology. She has combined academic research with advice for health authorities since 2008, both nationally (Pharmacovigilance expert for the Dutch Medicines Evaluation Board 2008-2016, Health Council of The Netherlands 2023-now) and internationally (European Commission appointed independent Scientific Expert of the Pharmacovigilance Risk Assessment Committee (PRAC), at the European Medicines Agency 2012-2018).
Marie has a strong background in epidemiology, was member of the steering group of the European Network of Centers for Pharmaco-epidemiology and Pharmacovigilance (ENCePP 2014-2016) and has applied quantitative methods from epidemiology to study regulatory science research questions. Working as a regulator has given her theoretical training about and hands-on experience in the functioning of the regulatory system. She has wide experience in leading public-private as well as academic research collaborations, nationally, at EU level and globally.
