Day1: November 16 [Thu], 2023

Session 1

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.)

Keynote 1

Why Do We Need Mucosal Vaccines
Prof. Hiroshi Kiyono
(Chiba University Future Mucosal Vaccine Research andDevelopment Synergy Center)

Session 2

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)

Keynote 2

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

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
Coffee Break[16:20-16:35]

Session 4

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

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)

Session 6

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)

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