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Monday, June 24 • 2:15pm - 3:15pm
#150: TFDA Town Hall: Focus on Regenerative Medicine

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-734-L04-P; CME 1.00; IACET 1.00; RN 1.00

Regenerative medicine is a potential treatment that can help repair or replace damaged or diseased human cells or tissues to restore normal function. This forum will discuss the regulatory aspects and experience with regenerative medicine.

Learning Objectives

Discuss regulations governing implementation or use of specific medical technology, examination, laboratory testing and medical devices; Describe the management of regenerative pharmaceutical products; Describe the experience of reviewing regenerative medicine affairs.


Shou-Mei Wu, PhD


New Regulation on Cell Therapy: Challenge and Prospect
Chung-Liang Shih, PhD

Regulation of Cell and Gene Therapy Products
Lien-Cheng Chang, PhD

Regulatory Considerations and Experiences for the Evaluation of Regenerative Medicinal Products
I-Ning Tang, MD, MSc

avatar for Chung-Liang Shih

Chung-Liang Shih

Director-General, Department of Medical Affairs, Ministry of Health & Welfare
Dr. Shih, Chung-Liang serves as the Director-General of Department of Medical Affairs, MOHW of Taiwan since 2016. From 2008 to 2012, he was the head of Bureau of Medical Affaires that oversees the health care system and leads the health care reform including the programs addressing... Read More →
avatar for I-Ning Tang

I-Ning Tang

Section Chief, Regulatory Science, Center for Drug Evaluation (CDE)
Dr. Tang is currently the Section chief of Regulatory science, Center of consultation at Taiwan Center for Drug Evaluation. Since joining in the regulatory science field in 2010, Dr. Tang has been involved in various projects. She is an experienced medical reviewer in evaluating market... Read More →
avatar for Shou-Mei Wu

Shou-Mei Wu

Director General, TFDA
Dr. Wu has been the Director-General of the Food and Drug Administration, Taiwan (TFDA) since February 2017. Now she is in charge of the overall policies. Under Dr. Wu’s leadership, TFDA have actively safeguarded food, drug, medical devices and cosmetics, and made best effort overcoming... Read More →
avatar for Lien-Cheng Chang

Lien-Cheng Chang

Section Chief, Division of Medicinal Products, TFDA
Lien-Cheng (Eric) Chang received his PhD degree from the Institute of Biopharmaceutical Sciences at Yang Ming University. Previously, he worked in Taichung Hospital and NTU Hospital in Clinical Pharmacy Services and also served in the former Bureau of Pharmaceutical Affairs for six... Read More →

Monday June 24, 2019 2:15pm - 3:15pm PDT
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum
  • Featured Topics Precision Medicine
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum