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1st Joint Conference of Taiwan and Japan on Medical Products Regulation

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Purpose:

  Globalization of development, manufacturing, trade, and marketing of pharmaceutical drugs has been progressing, and cooperation of regulatory activities amongst pharmaceutical regulatory agencies of each region has become a necessity. Nowadays, Asian countries have become significant in clinical development and manufacturing of drugs globally, and therefore, the collaborative relationship among the Asian regulatory agencies are becomes highly important. This symposium is the first joint conference being hosted by East Asia Relations Commission and Interchange Association, Japan, with focus on pharmaceutical regulations and health insurance system. The aim of this joint conference is to enhance mutual understandings, and to construct a basis in a cooperative system across the region for further development in pharmaceutical regulations and health insurance system. In a related development, between Japan and Taiwan, that both chairman Association on November 5, the Association of East Asian Relations has signed the MOU of 5 items including pharmaceutical, further exchanges increase future is expected.

Host:

East Asia Relations Commission
Interchange Association, Japan

Cohost:

Japan Pharmaceutical Manufacturers Association (JPMA)
Pharmaceuticals and Medical Devices Agency (PMDA)
Center for Drug Evaluation, Taiwan (CDE)
International Research-Based Pharmaceutical Manufacturers Association (IRPMA)
Taiwan Pharmaceutical Manufacturers Association (TPMA)
Taiwan Research-based Biopharmaceutical Manufacturers Association (TRPMA)

 

Date

23rd to 24th December, 2013

 

Venue

NTUH International Convention Center

Address:

No. 2, Xuzhou Road, Zhongzheng District 100, Taipei City

Phone

+886-2-77240-109

URL
 http://www.nthcc.com.tw/
 

Number of the attendees

200 attendees
 

Registration

Registration is accepted only in Taiwan.
 

Translation

Simultaneous translation to be provided for Japanese and Chinese
 

Agenda

Day 1 (December 23rd)

09:00-09:10

Welcome Speeches

09:10-09:20

Opening Remarks

Keynote Speeches:Health Insurance Issues

09:30-09:55

Update from Japan

Mr. Katsufumi Jo
  Director, Economic Affairs Division, MHLW

09:55-10:20

Update from Taiwan

Dr. Ru-Liang Shih
  Deputy Director, Medical Review and Pharmaceutical Benefit Division, NHIA

10:20-10:35

Input from Industry

Mr. Shinichiro Katayanagi, Executive Member, International Affairs Committee, JPMA

Keynote Speeches:Pharmaceutical Regulations Issues

11:00-11:25

Update from Japan

Dr. Taisuke Hojo, Senior Executive Director, PMDA

11:25-11:50

Update from Taiwan

Dr. Meir-Chyun Tzou, Director, Division of Medicinal Products, TFDA

11:50-12:05

Input from Industry in Japan

Mr. Tadaharu Goto, Director General, JPMA

12:05-12:20

Input from Industry in Taiwan

Mr. Calvin Tsai, CEO, Orient PHARMA Co. Ltd., TRPMA

Pharmaceutical Regulations Session

13:30-17:30  Contribution from Regulators

Review of New Drugs

  13:30-14:00

Dr. Daisaku Sato, Office Director, Office of New Drug V, PMDA

  14:00-14:30

Dr. Ming-Hsiao Chan, Director, Division of New Drugs, CDE

Review of Generic Drugs

  14:45-15:15

Dr. Kazuyuki Saito, Office Director, Office of OTC/Generic Drugs, PMDA

 

15:15-15:4

Mr. Chien-Liang Lin, Senior Specialist, Division of Medicinal Products, TFDA

Quality Issues related to GMP

 

16:15-16:45

Mr. Ichiro Tsunoi, Director, GMP Inspection, Office of GMP/QMS Inspection, PMDA

 

16:45-17:15

Ms. Chyn-Liang Huang, Chief Inspector/Section Chief, GMP Inspectorate, Division of Risk Management, TFDA

17:30-18:00  Wrap up and Conclusion of Pharmaceutical Regulatory Session

Day 2 (December 24th)

Health Insurance Session

09:00-12:15  Contribution from Regulators

Prices for Innovative Drugs and Patent-Expired Drugs

 

09:00-09:25

Mr. Hirokazu Hasegawa, Deputy Director, Economic Affairs Division, MHLW

 

09:25-09:50

Dr. Chui-Wen Kuo, Chief, Medical Review and Pharmaceutical Benefit Division, NHIA

Separation of Pharmacy and Clinic

 

10:05-10:25

Mr. Taihei Tanaka, Deputy Director, General Affairs Division, PFSB, MHLW

 

10:25-10:45

Ms. Hsueh-Yung Tai, Senior Specialist, Division of Medicinal Products, TFDA

Current Status on HTA

 

11:10-11:20

Dr. Raoh-Fang (Jasmine) Pwu, Director, Division of Health Technology Assessment, CDE

11:30-12:00  Wrap up and Conclusion of Health Insurance Session

Closing Remarks

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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