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Monday, June 25 • 3:00pm - 4:15pm
#150: TFDA Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-547-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Shou-Mei Wu, PhD


TFDA Perspective on Regulatory Management of Drug Development
Shou-Mei Wu, PhD

Global Challenges in Conducting MRCT and Interpreting Data
James Chih-Hsin Yang, MD, PhD

Using Real World Evidence in Regulatory Decision-Making
Churn-Shiouh Gau

The Development of Pharmaceutical Industry in Taiwan
Annie Tsu-Hui Liu

avatar for Churn-Shiouh Gau

Churn-Shiouh Gau

Executive Director, Center For Drug Evaluation, Taiwan
Dr. Churn-Shiouh Gau is the Executive Director of Center for Drug Evaluation, Taiwan and the adjunct professor of School of Pharmacy, National Taiwan University. She has more than 20 years experience on drug evaluation specialized in CMC. She was the project leader for the establishing... Read More →
avatar for Annie Tsu-Hui Liu

Annie Tsu-Hui Liu

Director, Office of Science and Technology, Executive Yuan
Dr. Tsu-Hui Annie Liu is currently the Director of Biotechnology, Health, Medicine and Agriculture Division, Office of Science and Technology, Executive Yuan, Taiwan. Dr. Liu has more than 20 years of broad experience in biotechnology related field from basic research, drug development... Read More →
avatar for Shou-Mei Wu

Shou-Mei Wu

Director General, TFDA
Education Ph.D. Pharmaceutical Analysis, School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan Personal Experiences Visiting fellow, School of Chemistry University of Virginia, Virginia, US and School of Pharmacy, Tokushima University, Japan Dean, College of Pharmacy... Read More →
avatar for James Chih-Hsin Yang

James Chih-Hsin Yang

Director, Department of Oncology, NTU Hospital
Dr. Yang’s research focuses on lung cancer treatment and the mechanism of multidrug resistance of chemotherapy therapy and targeted therapy. Dr. Yang is a global leader in lung cancer clinical studies, especially in the new drug development in EGFR mutant lung cancer. He published... Read More →

Monday June 25, 2018 3:00pm - 4:15pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum