Program
Day1: November 16 [Thu], 2023
Session 1
9:00～10:20
Latest Clinical Research in Asia
Protecting Kawasaki disease against coronary artery aneurysms
- Prof. Hiromichi Hamada
- （Chiba University）
Conducting Clinical Trials in Asia: from global Contract Research Organization(CRO) perspective
- Ms. Olivia Chung
- （IQVIA Services Japan K.K.）
Suture Embedding Acupuncture for Chronic Low Back Pain: A Randomized, Sham-Controlled Clinical Trial.
- Prof. Meng-Huang Wu
- （Taipei Medical University Hospital）
Learning from clinical trials in Asia
- Ms. Natsuko Oda
- （Shionogi & Co., Ltd.）
Break［10:20～10:40］
Keynote 1
10:40～11:20
Why Do We Need Mucosal Vaccines
- Prof. Hiroshi Kiyono
- （Chiba University Future Mucosal Vaccine Research andDevelopment Synergy Center）
Lunch［11:20～12:50］
Session 2
12:50～14:10
Clinical Research in the Post-COVID-19 Era
Clinical Research during COVID-19 Pandemic: Reflections and Lessons Learnt
- Dr. Hor Chee Peng
- （Seberang Jaya Hospital）
Development of a Multiregional Clinical Trials Platform towards pandemic preparedness
- Ms. Marlinang Diarta Siburian
- （National Center for Global Health and Medicine）
Implementing Decentralized Clinical Trials and Remote Monitoring Systems:Adapting to Pharmaceutical Needs in the Post-COVID-19 Era
- Prof. Shian-Ying Sung
- （Taipei Medical University）
Advanced Regenerative Medicine Clinical Trials
- Prof. Sung Yong Oh
- （Dong-A University Hospital）
Break［14:10～14:25］
Keynote 2
14:25～15:05
PMDA’s approaches to accelerate innovative drug/medical device development in the Post-COVID-19 Era
- Dr. Yasuhiro Fujiwara
- （Pharmaceuticals and Medical Devices Agency）
Coffee Break［15:05～15:20］
Session 3
15:20～16:20
GCP Renovation and Recent Development of RBA
Update and future perspectives on ICH E6(R3)
- Dr. Yoshiko Komuro
- （Pharmaceuticals and Medical Devices Agency）
A New Era of Risk-Based Quality Management: Driven by Innovation
- Ms. Yumi Sugiura
- （Bristol Myers Squibb）
A fit-for-purpose Risk Based Quality Management operational strategy
- Mr. Luis Segovia Sordo
- （Parexel）
Coffee Break［16:20-16:35］
Session 4
16:35～17:55
DX（Digital Transformation）and R&D
Patient-centric Data Acquisition Methods for DCT
- Mr. Tom Lim
- （CareSquare Inc.）
Development of digital cognitive behavioral therapy
- Prof. Eiji Shimizu
- （Chiba University）
Transforming Clinical Trials: How Marken Facilitates Decentralized Trial Operations
- Mr. Minoru Mihara
- （Marken Ltd）
The Role of Pharma in Academic Drug Discovery in Japan
- Mr. Mitsuhiro Okamoto
- （AstraZeneca K.K.）
Day2: November 17 [Fri], 2023
Session 5
9:00～10:45
Examples of Clinical Research Support at AROs
New remission induction regimen with low-dose steroid and rituximab for ANCA-associated vasculitis
- Dr. Shunsuke Furuta
- （Chiba University Hospital）
What academia should do, what academia can do. ~with the report from US ~
- Dr. Tomoya Kurokawa
- （Chiba University Hospital）
Multicenter Collaboration with Stakeholders Engagement in Clinical Research: Ways Forward
- Dr. Hor Chee Peng
- （Seberang Jaya Hospital）
Study Management in Chiba University Hospital Clinical Research Center
- Ms. Haruna Ebisu
- （Chiba University Hospital）
Study Management for Investigator-Initiated Clinical Trials - Swimming with the Tide of QMS/RBA
- Mr. Asahi Takahashi
- （Chiba University Hospital）
The monitoring activities for clinical trials
- Ms. Eri Imanishi
- （Chiba University Hospital）
Clinical Data Management in Chiba University Hospital Clinical Research Center
- Ms. Kirika Murakami
- （Chiba University Hospital）
Break［10:45～11:00］
Session 6
11:00～12:15
Presentations from REACTA forum board members
2023 REACTA: What is an industry leader?
- Mr. Anthony VA Nguyen
- （Dong-A Univerisity Hospital）
CRM Delivering MRCT through Humanity, Stability and Sustainability
- Dr. Akhmal Yusof
- （Clinical Research Malysia）
Establish Sustainable Success Model: Merging Pragmatism and Empathy in the TMU ARO
- Prof. Shian-Ying Sung
- （Taipei Medical University）
DAUH Clinical Trial Center Status Update
- Prof. Sung Yong Oh
- （Dong-A University Hospital）
A lesson from the covid-19 pandemic and CCRC activities
- Prof. Hideki Hanaoka
- （Chiba University Hospital）
