Dr. Hsien-Yi Lin received his PhD and postdoctoral training in the field of molecular biology. In the field of medical device regulation, he has been working for Center of Drug Evaluation and Taiwan FDA since 2007. His current job title in Taiwan FDA is Senior Reviewer.
PRESENTER
(S):
Chien-Liang Lin, Food and Drug Administration, Department of Health, Taiwan
Wallace is Director for Resource Development of CDE. He was Advisor for MOEA, President of SyNovate, Associate Professor in National Chao-Tune Univ. He has worked in Carnegie-Mellon Univ. and in Medical School of Univ. of Pittsburgh after earned Ph.D. from Carnegie-Mellon Univ., in Pittsburgh, PA.
Shun Jin, Takeda Global Research & Development Center, Inc., Singapore
Jin Shun, regulatory associate director of Takeda R&D, has been worked in pharma/CRO companies including Nycomed, J&J, GE Healthcare and Parexel. He has been engaged in regulatory submissions, advice and strategic decision in Asia especially in China. He is a pharmacist with MBA degree.
Neil McAuslane, Centre For Innovation In Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science and works in the area of regulatory strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh.
Description
With global development, Asian regulatory agencies are streamlining the clinical trial process. Taiwan is adapting the Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) system. Korea and Japan have enhanced the review of the clinical trial. This session will discuss revolutionary measures and impacts.
Learning Objectives: Describe the recent revolutionary measures of streamlining the clinical trial review process in the Asian Pacific region Compare the various models in Asian Pacific region among Asian countries such as Taiwan, Korea, and Japan Discuss the impact on regulatory affairs/new drug development in the Asian Pacific region.