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Monday, June 27 • 8:30am - 9:45am
#111: Global Regulatory Harmonization in Asia: Is a New Trend Occurring?

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recently we have seen increased efforts of Asian regulatory harmonization. Hear speakers from Asian agencies and industry and learn how they try to collaborate and harmonize regulations to enable more efficient drug development in this emerging region.

Learning Objectives

Discuss recent changes in drug development regulations in Asia; Describe the Asian regulation trend relating to harmonization with ICH and other global initiatives; Identify how the industry and regulatory agencies collaborate with each other for better and faster drug development by reviewing recent examples of global drug development utilizing multiregional clinical trials including Asia.


Akio Uemura, PhD


Update on Clinical and Regulatory Environment for Drug Development in Korea
Min Soo Park

Rapidly Changing Regulatory Landscape in China
Dan Zhang

Impacts of ICH E17 Guideline in Asian Drug Development
Yoshiaki Uyama, PhD

avatar for Akio Uemura

Akio Uemura

Executive Director, Head of Japan Development, Allergan Japan K.K.
1996: Head of biosciences lab, Mochida Pharmaceutical, 2000: Director, project management, EL Japan, 2004: Clinical phase global project manager, Eli Lilly, 2007: Director, regulatory policy, liaison and intelligence, EL Japan. 2011: Head of Japan Regulatory Affairs, Allergan Japan... Read More →

avatar for Min Soo Park

Min Soo Park

Chair, KCGI
Min Soo Park is a physician, trained specialist and Professor in Pediatrics (Neonatology) and Clinical Pharmacology. He received MSc in Clinical Pharmacology at Univ of Aberdeen, UK, and Ph.D. in Medicine at Ajou University, Korea. He served as VP of KoNECT and is in charge of clinical... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
Yoshiaki Uyama, PhD, is Director, Office of Medical Informatics and Epidemiology, for the Pharmaceuticals & Medical Devices Agency (PMDA), Japan. His experience in the safety review and assessment of new drugs for PMDA includes serving as the Review Director; as International Conference... Read More →
avatar for Dan Zhang

Dan Zhang

Executive Chairman, Fountain Medical Development Ltd. (FMD)
Dr. Dan Zhang, the Executive Chairman of Fountain Medical Development, has more than 15 years of drug development experience. Previously, Dr. Zhang was the Head of Clinical Development and Global Safety Assessment at Sigma-Tau Research Inc., Vice President at the Quintiles Transnational... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session