Symposium 12: Leveraging regulatory pharmacoepidemiology for informed decision making in Asia
Tracks
Track 1
| Monday, October 14, 2024 |
| 14:00 - 15:30 |
| Yasuda Auditorium |
Details
In Asian region, similarly in the rest of the world, the value of the real-world data (RWD)/ evidence (RWE) has been increasing. The pivotal clinical trial data informing the regulatory decision making for initial marketing authorization have usually been generated in the trials in which Asian are under-represented and not considered differences in local clinical practice and therefore not ready to be generalized to estimate benefits and risks in Asian population. Asian RWD/RWE is expected to supplement those data and to inform regulatory/reimbursement decisions. Given that Asian population represents more than 60% of world population and recent issuance of regulatory guidance for burgeoning pharmacoepidemiological studies in Asian countries/regions, the inequality in the data underpinning regulatory decision making for pharmaceutical products could be further mitigated through the approach to the common foundation/flamework leveraging use of Asian RWD in pharmacoepidemiological studies.
Audience and the Societies are to learn and discuss the perspectives and potential collaboration on regulatory use of pharmacoepidemiological studies to generate Asian specific RWE.
Speaker
In-sook Park
Director General
Korea Regulatory Science Centre
Presenter
Biography
[Career Profile]
○ Dec. 2022 - Present
Director General, Korea Regulatory Science Center
○ April 2023 - Present
Affiliated professor, Korea National Institute for Bioprocessing Research and Training (K-NIBRT), Yonsei University
○ Mar. 2020 - Dec. 2022
Director General, Biopharmaceutical and Herbal Medicine Evaluation Department, Ministry of Food and Drug Safety, Korea (MFDS)
○ Jan. 2011 - Mar. 2020
Director, MFDS
• Research Planning and Coordination Division
• Pharmaceutical Standardization Division
• Gastroenterological Drug Division
• Dental and Gastroenterology Device Division
○ Feb. 2001 - Jan. 2011
Senior Scientific Officer, MFDS
• General Pharmacology Division
• Pharmaceutical Equivalence Division
• Drug Approval and Review Management Division
○ Sep. 1990 - Feb. 2001
Scientific Officer, General Pharmacology Division, National Center for Toxicological Sciences
[Educational Background]
○ Ph.D. in Pharmacology, Chungbuk National University (Feb. 1999)
○ M.S. in Social Pharmacy, Sookmyung Women's University (Aug. 2010)
○ M.S. in Pharmaceutical Life Science, Yeungnam University (Aug. 1989)
○ B.S. in Pharmacy, Yeungnam University (Feb. 1987)
Dr. Lih-jiuan Hsu
Deputy Executive Director
Center for Drug Evaluation, Taiwan
Presenter
Biography
Dr. Lih-jiuan Hsu joined Center for Drug Evaluation (CDE), Taiwan in 2002, leading CDE previously as Director of Division of New Drugs, Center of Consultation, and Senior Executive Officer in Office of Executive Director, devoting herself in the development of regulatory science in Taiwan for more than 20 years. Besides Deputy Executive Director of CDE, Dr. Hsu is also the Adjunct Attending Physician of Family Medicine in National Taiwan University Hospital (NTUH) and the Thesis Advisor in Department of Pharmacy and Graduate Institute of Clinical Pharmacy in National Taiwan University (NTU). Before joining CDE, Dr. Hsu was a practicing family physician. Dr. Hsu obtained her MD degree from China Medical University, Taiwan.
Yoshiaki Uyama
Associate Executive Officer
Pharmaceuticals and Medical Devices Agency
Presenter
Biography
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a member of the DIA Council of Regulators and a board member of the international society for pharmacoepidemiology as well as a visiting professor in (Graduate School of Medicine), Chiba University (Graduate School of Medicine) and Nagoya City University (Graduate School of Pharmaceutical Science).
Dr. Kazuhiro Kajiyama
Senior Reviewer
Pharmaceuticals and Medical Devices Agency (PMDA)
Presenter
Biography
Dr. Kazuhiro Kajiyama is a senior epidemiological safety reviewer of Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He graduated with a PhD in computational biology from Yokohama City University in 2013, and started to work on post-marketing drug safety assessment in PMDA. His current work is evaluating drug safety by utilizing medical information database such as MID-NET and the national claims database in Japan. He is a member of ICH M14 expert discussion group as a regulatory chair and a technical expert.
Moderator
Hisashi Urushihara
Professor
Keio University
Yoshiaki Uyama
Associate Executive Officer
Pharmaceuticals and Medical Devices Agency
