Event Information

Time: 09:00-16:30, December 1, 2012

Venue: Howard Civil Service International House
(No.30, Sec. 3, Xinsheng S. Rd., Taipei, Taiwan)

TFDA commissioned NCKU Health Outcome Research Center and TRPMA to co-organize this symposium on Regulation of Monoclonal Antibodies Drugs. The purpose of this symposium is to probe into current situation of domestic industry and regulatory and get future policy management consensus between government, industry, scholars and researchers.

Agenda:

 Time

Content

Speaker

 09:00~09:30

Registration

   09:30~09:35

Opening Remarks

National Cheng Kung University
Prof. Yea-Hue Kao

 09:35~09:40

Remarks

Section Chief, TFDA
Dr. Meir-Chyun Tzou

 09:40~10:40

Current Development Status of Monoclonal Antibodies Drugs: Technology Aspect

Vice President, Biological Product Division
Dr. Shugene Lynn

 10:40~11:00

Break

   11:00~12:00

Current Development Status of Monoclonal Antibodies Drugs: Economy Aspect

President, Mycenax Biotech Inc.
Dr. Karen Wen

 12:00~13:30

Lunch

   13:30~15:10

Regulatory Discussion: Biosimilar mAbs applied as new drug with new compositions
●EU/US Biosimilar Regulatory Comparison
●EMA mAb guidance
●Taiwan Regulatory Discussion

NCKU
Prof. Jin-ding Huang

 15:10~15:30

Break

   15:30~16:30

Panel discussion

Director General, Dr. Jaw-Jou Kang
Section Chief, Dr. Meir-Chyun Tzou
Dr. Shugene Lynn
Dr. Karen Wen
Dr. CJ Chang
Prof. Yea-Hue Kao
Prof. Jin-ding Huang
All Participants

(來源：健康醫療網 2012-12-16)