Justina Molzon (Dr.)

Associate Director
International Program Center for Drug Evaluation and Research
US FDA

Introduction

Byung-won Jang (Mr.)

Director General
Pharmaceutical Safety Bureau
Korea FDA

Keynote

Yuki Ando (Ms.)

Principal Reviewer for Biostatistics
Office of New Drug II
PMDA

Day 1 > Session 1-1

James Hung (Dr.)

Director
Division of Biometrics I, Office of Biostatistics Center for Drug Evaluation and Research
US FDA

Day 1 > Session 1-2

Wei Li (Dr.)

Professor
Division of Biometrics National Center for Cardiovascular Diseases
China

Day 1 > Session 1-3

Mey Wang (Dr.)

Statistical Team Leader
Division of Clinical Science Center for Drug Evaluation
Chinese Taipei FDA

Day 1 > Session 1-4

William Wang (Dr.)

Head of Asia Pacific Hub
Biostatistics and Research Decision Sciences Merck Research Laboratories
Merck & Co, Inc

Day 1 > Session 1-5

Cornelia Weber (Dr.)

Senior Clinical Pharmacologist
Pharma Research and Early Development
Roche Ltd.

Day 1 > Session 2-1

Michael Humphries (Mr.)

Chief Scientific Officer
Greater China Region
Novartis China

Day 1 > Session 2-2

DongHo Lee (Dr.)

Vice President of KoNECT / Executive Director
Asan Medical Center Clinical Research Center
Korea

Day 1 > Session 2-3

Yoshihiro Arakawa (Mr.)

Associate Professor and Vice Director
Clinical Research Support Center / The University of Tokyo Hospital
Japan

Day 1 > Session 2-4

Catherine Lee (Dr.)

Area Head
Clinical Operations Asia
Pfizer Inc

Day 1 > Session 2-5

Zhou Honghao (Dr.)

Institute of Clinical Pharmacology, Central South University
Member of Chinese Academy of Engineering
China

Day 2 > Session 3-1

Masahiro Tohkin (Dr.)

Section Chief
National Institute of Health Sciences
Division of Medicinal Safety Science
Japan

Day 2 > Session 3-2

Injin Jang (Dr.)

Professor
Seoul National University
Korea

Day 2 > Session 3-3

Yang Zhimin (Dr.)

Deputy Director
3rd Branch, Center for Drug Evaluation
SFDA

Day 2 > Session 3-4

Yoshiaki Uyama (Dr.)

Review Director
Office of New Drug III
PMDA

Day 2 > Session 3-5

Jungyun Chang (Dr.)

Senior Reviewer
KFDA

Day 2 > Session 3-6

Li Jinju (Dr.)

Director
Division of Drug Research Supervision / Dept. of Drug Registration
SFDA

Day 2 > Session 4-1

Shinobu Uzu (Dr.)

International Planning Director
MHLW

Day 2 > Session 4-2

Soon-wook Hong (Dr.)

Director
Pharmaceutical Safety Policy Division
KFDA

Day 2 > Session 4-3

Maggie Chang (Dr.)

Director
Drug Regulatory & Medical Affairs
RDPAC, China

Day 2 > Session 4-4

Tetsuomi Takano (Dr.)

Head of Asian Project Management Asian Development
Astellas Pharma Inc.
JPMA

Day 2 > Session 4-5

Kyung-mi Park (Dr.)

Hanmi Pharm. Co., Ltd
KPMA
Korea

Day 2 > Session 4-6

Atsushi Ohtsu (Dr.)

Director
Research Center for Innovative Oncology / National Cancer Center Hospital
Japan

Day 3 > Session 5-1

Baek-Yeol Ryoo (Dr.)

Associate Professor
Department of Oncology
ASAN Medical Center, Korea

Day 3 > Session 5-2

Herng-Der Chern (Dr.)

Executive Director
Center for Drug Evaluation
TFDA

Day 3 > Session 5-3

Steve Kim (Dr.)

Medical Director
Merck
Korea

Day 3 > Session 5-4

Christine Dela Cruz (Dr.)

Asia-Pacific Group Director for Oncology
Global Clinical Research
BMS

Day 3 > Session 5-5

Mike Ward (Mr.)

Manager
International Program Division
Therapeutic Products Directorate
Health Canada / Chair, APEC Regulatory Harmonization Steering Committee

Concluding Remarks