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
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 | ||