Keynote Speech
Mr. Akihiko Matsubara JPMA, Japan
Overview of APAC project - Introduction 

Panel Discussion Part I
Mr. Isao Sasaki Astellas/JPMA, Japan
Dr. Churn-Shiouh Gau Executive-Director, Center for Drug Evaluation (CDE)
Mr. Kum Cheun Wong Novartis 
Ms. Justina Molzon Former US FDA, United States

Panel Discussion Part IPanel Discussion Part II
Ms. Sukanya Jiarapong Thailand FDA, Thailand 
Ms. Eisha Abdul Rahman Pharmaceutical Services Ministry of Health, Malaysia 
Ms. Jayanthi Boobalan Pfizer, Malaysia

Session 5: Evolving and Establishing Regulatory Framework for Multi-Regional Clinical Trials (MRCTs)
Dr. Yasuko Asahina PMDA, Japan 
Prof. Oliver Yoa-Pu Hu SIG, FIP, Taiwan
Hsiang-Ing Pan TFDA, Taiwan 
Angela Yan RDPAC, China 
Mr. Tony Guo MSD Ltd., China

Hot Topics II: Regulatory convergence – update on regional harmonization initiatives with a particular focus on APEC

Ms. Justina Molzon 
Former US FDA, United States 
Example of a future Center of regulatory Excellence (CoRE): The MRCT Pilot in collaboration with Duke-NUS
Mr. Kiminori Nagao
APAC Chair, Japan 
Industry Perspective on regulatory convergence within the APEC region 

Closing Panel Discussion 
Dr. Junko Sato PMDA, Japan 
Dr. Li-Ling Liu TFDA, Taiwan 
Mr. Kiminori Nagao APAC, Japan
Mr. Chih-Ping Yang IRPMA, Taiwan