Symposium 5: Use of Real-world data for regulatory decision making: the value of collaborations
Tracks
Track 1
| Sunday, October 13, 2024 |
| 14:45 - 16:15 |
| Yasuda Auditorium |
Details
The integration of real-world data (RWD) to generate real-world evidence (RWE) into regulatory decision-making processes has become increasingly significant, offering valuable insights that complement traditional clinical trial data. Factors such as the nature of today’s innovative medicines that are being put on the market, as well as the need for rapid evidence generation are two of the pivotal aspects that have fuelled this development. This development has also spurred a need for guidance, and during the past years several RWD/ Real world evidence (RWE) guidances documents have been published by regulatory agencies world wide. These agencies, depend to a large extent on research institutions or the pharmaceutical industry to conduct RWD/RWE studies to generate the evidence needed, and only a few have in-house capacity to conduct their own studies. As a result, several collaborations have been established to facilitate the conduct of RWD studies for regulatory decision making. Many of these include collaborations where different types of databases are used, sometimes from different countries. This poses challenges related to heterogeneity in both the data source, the data specifics and the populations that these might represent. However, these collaborations have also resulted in improved transparency, better data sharing practices, and the development of analytical processes for multi-database/multi-country studies.
This symposium provides an opportunity to exchange experiences and information on different types of RWD and RW databases used to inform regulatory decision making. In addition, it will provide insights into the potential facilitations and barriers for both regional as well as global collaborations. The symposium will also facilitate better understanding of data and data sources within and outside Asia.
Speaker
Helga Gardarsdottir
Professor Real world data for decision making on medicines
Utrecht University
Presenter
Biography
Helga Gardarsdottir is professor in use of Real world data for decision making on medicines at the Division of Pharmacoepidemiology & Clinical Pharmacology (Utrecht University, NL). Additionally, she holds the position of adjunct professor of Pharmacoepidemiology at the University of Iceland in Reykjavik.
Her primary research interests include the application and development of innovative approaches to generate and analyse real world data on safety and effectiveness of medicines to inform regulatory and clinical decision making. Her special research interest involve assessing impact of drug regulation on safe and effective use in populations. Prof Gardarsdottir was trained as a pharmacist (SE) and a pharmacoepidemiologist (NL). She has led and participated in several international multi-country research projects including the IMI-PROTECT project, the IMI Trials@home project and several EMA tendered studies on behalf of the EU Pharmacoepidemiology and Pharmacovigilance Research Network. She is the co-chair of the ENCePP steering group, a member of the ENCePP working group responsible for the “Guide on Methodologal Standards in Pharmacoepidemiology“, co-led the Real-World Evidence Task Force of the International Society of Pharmacoepidemiology (2019-2022) and is an associate editor of the journal ‘Pharmacoepidemiology & Drug Safety’
Prof. Olaf Klungel
Utrecht University
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. In addition to his research, 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.
Prof. Edward Lai
Educational Program Director
National Cheng Kung University
Presenter
Biography
Associate Professor Edward Chia-Cheng Lai specializes in pharmacoepidemiology, with a focus on research projects using cross-center and cross-national databases. He has received solid training in research methodology. He has published approximately 90 research papers in top-tier journals, including BMJ, Annals of Internal Medicine, and Clinical Pharmacology & Therapeutics. His articles have been cited over 1,000 times. Recognized for his outstanding performance in research methodology, he was invited to become the Associate Editor of the official journal of the International Society for Pharmacoepidemiology (ISPE), Pharmacoepidemiology and Drug Safety, in 2013. He reviews over 30 research papers annually and invites more than 100 domestic and international reviewers to assist in the peer-review process, demonstrating significant academic influence.
Prof. Kristian Filion
McGill University
Presenter
Biography
Dr Filion is an Associate Professor and William Dawson Scholar in the Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health of McGill University and a Senior Investigator at the Centre for Clinical Epidemiology of the Jewish General Hospital in Montreal, Canada. His research interests include pharmacoepidemiology and drug safety, knowledge synthesis, and cardiovascular epidemiology. He uses large, population-based databases to study the utilization, effectiveness, and safety of commonly prescribed medications, with a particular interest in cardiometabolic conditions (hypertension, heart disease, and diabetes), including studies of drugs used to treat them and cardiometabolic outcomes. He is a Steering Committee Member of the Canadian Network for Observational Drug Effect Studies (CNODES), a pan-Canadian network that addresses drug safety and effectiveness for government partners. Dr. Filion is a Fellow of the American Heart Association.
Assoc Prof. Ju-Young Shin
Sungkyunkwan University (SKKU)
Presenter
Biography
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health’. She received her B.S. in pharmacy from Seoul National University, MPH in health policy and Ph.D. in pharmacoepidemiology from the Seoul National University College of Medicine. She was working as a director at Korea Institute of Drug Safety and Risk Management (KIDS), university of South Australia as a visiting fellow and McGill University as a postdoctoral fellow. She published more than 200 peer-reviewed journal including prominent journal such as British Medical Journal (BMJ), Gut, Diabetes care, and Clinical Infectious Disease. Her area of research was vaccine safety, biologics, and bone related epidemiology. She also led several governmental projects funded by Ministry of Food and Drug Safety, Ministry of Health and Welfare, and Health Insurance Review and Assessment Service and projects sponsored by pharmaceutical industry. She is currently a member of board of directors of Korea society of Pharmacoepidemiology and Risk Management (KoPERM), Korea Society of Epidemiology, and Korea Academy of Social and Managed Care Pharmacy (KASMCP).
Dr Kenneth Man
UCL
Presenter
Biography
Kenneth Man is a medical statistician and epidemiologist serving as a Lecturer/Assistant Professor in Pharmacoepidemiology at the UCL School of Pharmacy, London. With extensive experience in medication research utilising Real-World Data from large healthcare databases, Kenneth’s research is focused on paediatric, psychiatric and perinatal pharmacoepidemiology including the safety and effectiveness of medication use, prenatal medication exposures, and global psychotropic medication utilisation. He has been recognised with the Kramer-Pollnow Prize in 2023 and has previously chaired the Asia Pharmacoepidemiology Network (AsPEN).
Moderator
Helga Gardarsdottir
Professor Real world data for decision making on medicines
Utrecht University
Olaf Klungel
Utrecht University
