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TFDA Town Hall
Session Chair(s)
Shou-Mei Wu, PhD
Director-General
TFDA, Taiwan
The safety, quality, and effectiveness of drugs are closely entwined with our daily lives and health. The Taiwan Food and Drugs Administration (TFDA) has played a crucial role in promoting public health and continued to enhance a comprehensive drugs safety management system. During this forum, TFDA will share the updated information of regulatory management of drug development, challenges of MRCT implementation, the application of real world evidence, and innovative biotechnological medicine.
Learning Objective : Discuss an overview of TFDA expectations for regulatory management of drug development; Describe the challenges in conducting and analyzing MRCT data and in applying real-world data in regulatory decision making; Describe the latest development of biotechnological medicine.
Speaker(s)
TFDA Perspective on Regulatory Management of Drug Development
Shou-Mei Wu, PhD
TFDA, Taiwan
Director-General
Global Challenges in Conducting MRCT and Interpreting Data
James Chih-Hsin Yang, MD, PhD
NTU Hospital, Taiwan
Director, Department of Oncology
Using Real World Evidence in Regulatory Decision-Making
Gau Churn-Shiouh, DrSc
Project Office of Sustainable Platform For Big Data In Health By MOHW, Ching-Kan, Taiwan
Office Director
The Development of Pharmaceutical Industry in Taiwan
Annie Tsu-Hui Liu
Executive Yuan, Taiwan
Director, Office of Science and Technology
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