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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)
Shou-Mei Wu, PHD
Director-General, TFDA, Taiwan
TFDA Perspective on Regulatory Management of Drug Development
James Chih-Hsin Yang, MD, PHD
Director, Department of Oncology, NTU Hospital, Taiwan
Global Challenges in Conducting MRCT and Interpreting Data
Gau Churn-Shiouh, DRSC
Office Director, Project Office of Sustainable Platform For Big Data In Health by MOHW, Ching-Kan, Taiwan
Using Real World Evidence in Regulatory Decision-Making
Annie Tsu-Hui Liu
Director, Office of Science and Technology, Executive Yuan, Taiwan
The Development of Pharmaceutical Industry in Taiwan
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