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Events and Symposia

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

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  1. Date
  2. Venue
  3. Number of Participants
  4. Registration
  5. Interpretation
  6. Agenda
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

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