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 joint conference being hosted by Taipei Economic and Cultural Representative Office and Interchange Association, Japan, with the aim 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 under the MOU of 5 items signed between Taiwan and Japan on 5th November 2013. As it is the 2nd symposium, the agenda is aiming to deepen the discussion on pharmaceuticals and medical devices from the perspectives of regulation and health insurance system.
Host:
Taipei Economic and Cultural Representative Office
Interchange Association, Japan
Support:
Pharmaceuticals and Medical Devices Agency
Center for Drug Evaluation
Japan Pharmaceutical Manufacturers Association
Japanese Chamber of Commerce & Industry Taipei
International Research-based Pharmaceutical Manufacturers Association
Taiwan Pharmaceutical Manufacturers Association
Taiwan Research-based Pharmaceuticals Manufactures Association
Japan Federation of Medical Devices Associations (JFMDA)
Taiwan Medical and Biotech Industry Association
Taiwan Federation of Medical Device Commercial Associations
Taiwan Generic Pharmaceutical Association
Chinese Pharmaceutical Manufacture and Development Association
Japan Self-Medication Industry (JSMI)
Asia-Pacific Self-Medication Industry (APSMI)
Taiwan Pharmaceutical Marketing & Management Association (TPMMA)
Date *The seminar was already held*
31st October, 2014Venue
Keynote lecture (joint program of pharmaceuticals and medical devices) :
Nihonbashi Sunsky room
Address:
4th floor of Sanshin Muromachi bulding,
3-2-8 Nihonbashi-muromachi, Chuo-ku, Tokyo 103-0022
Phone:
03-3516-3481
FAX:
03-3277-2639
* After the keynote lecture session, the meeting venue will be separated for "pharmaceuticals" and "medical devices" as follows
1) Medical devices
Nihonbashi Sunsky room: same as the keynote lecture session
2) Pharmaceuticals
Japan Pharmaceutical Manufacturers Association
Address:
Torii Nihonbashi,
3-4-1 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023
Phone:
03-3241-0326
FAX:
03-3242-1767
Number of the attendees
150 attendees
Registration and inquiries
*Registration Closed*
Please register to attend the conference via below website;
Japanese
https://www.praise-net.jp/pn/m/e.asp?id=NjEzMw (Currently not available)
English
https://www.praise-net.jp/pn/m/e.asp?id=NjEzNQ (Currently not available)
Inquiries
Japan Pharmaceutical Manufacturers Association
Shibata,
Office of International Programs
Tel:
03-3241-0326
Fax:
03-3242-1767
E-mail:
Japan Federation of Medical Devices Associations (JFMDA)
Tanaka, Naito,
Office of International Programs
Tel:
03-5225-6234
Fax:
03-3260-9092
E-mail:
Registration Fee
Free
* JPY 5000 per person will be charged for the attendees to the welcome receptions
Interpretation
Simultaneous translation to be provided for Japanese and Chinese
Agenda (October 31st)
Pharmaceuticals and Medical devices
08:30-08:40
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Opening remarks
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08:40-10:00
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Keynote lecture (TFDA/NHIA/PMDA and industry input)
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Pharmaceuticals Regulation session |
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11:00-12:30
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MRCT and New drug review
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Japan:
"Recent experiences to review data from MRCTs and progress of research on ethnic factors" Dr. Yoshiaki Uyama, Division Director, Division of Epidemiology, Office of Safety I,*PMDA (30min) Taiwan: “Clinical Trial Capacity and New Drug Reviews Related to MRCTs in Taiwan” Dr. Chi-Hsun Chen, Team Leader, Center for Drug Evaluation (30min) Q&A: 30min |
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14:00-15:00
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Regenerative products
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Japan:
"Regulatory Reform for Regenerative Medicine in Japan" Dr. Daisaku Sato, Director, Office of Cellular and Tissue-based Products,* PMDA (20min) Taiwan: "Regulation of cell therapy products in Taiwan" Dr. Yi-Chu Lin, Associate Researcher, Division of Medicinal Products, TFDA (20min) Q&A: 20min |
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15:00-16:00
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Nano technology and products
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Japan:
"Evaluation of nanotechnology-based medicines" Dr. Naomi Nagai, Principal Senior Scientist, Center for Product Evaluation, * PMDA (20min) Taiwan: “Regulatory Considerations for Nanotechnology-related Drug Products in Taiwan” Dr. Lin-Chau Chang, Team Leader, Center for Drug Evaluation (20min) Q&A: 20min |
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16:30-17:30
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OTC
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Japan:
"Regulation of OTC Drugs in Japan" Dr. Takatoshi Nakamura, Director, Office of OTC/Generic Drugs,* PMDA (20min) Taiwan: "Introduction of OTC regulations in Taiwan" Mr. Heng-Jung Lien, Section Chief, Division of Medicinal Products, TFDA (20min) Q&A: 20min |
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17:30-17:45
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Closing and summary
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Medical devices | ||
11:00-11:50
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Overall topics (PMS, GCP, Registration, QSD/QMS)
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PMS (Taiwan)
"Report on Collaborative Activities Related to Medical Device Post Market Surveillance (PMS) System" Ms. Yu-Wen Huang, TFDA (10min) GCP (Japan) "GCP WG Activity Report" Mr. Hideyuki Kondo, MHLW (10min) Product Registration (Taiwan) "Progress of Product Registration Working Group" Mr. Ta-Jen Wu, TFDA (15min) QSD/QMS (Japan) "Report on collaborative activities related to QSD/QMS" Mr. Hideki Asai, (15min) |
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12:00-12:30
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Q&A and wrap-up
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Health Insurance session | ||
14:20-14:30
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Opening remarks
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Japan:
Mr. Katsufumi Jo, Director, Economic affairs division Health policy Bureau Taiwan: Dr. San Kuei Huang, Director- General, NHIA |
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14:30-15:30
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Access to New drugs 1
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Japan:
"A Measure to Ensure Transparency and Efficiency in Drug Pricing System" Mr. Shinichi Takae, Deputy Director, Economic affairs, Health policy Bureau, MHLW Taiwan: "Efficiency and transparency in pricing" Mr. Shang-ping Chen, Senior Executive officer NHIA |
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15:50-16:50
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Access to New drugs 2
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Japan:
"National Health Insurance Pricing formula in Japan" Mr. Yasuhiro Matsunaga, Japan Pharmaceutical Manufacture Association Taiwan: "Policy for reimbursing orphan drugs" Mr. Shang-ping Chen, Senior Executive officer, NHIA |
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16:50-17:30
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Separation of medical and dispensary practice
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"Separation of Dispensing and Prescribing Drugs in Japan"
Mr. Katsuaki Ura, Assistant Director of General Affairs Division, Pharmaceutical and Food Safety Bureau, MHLW |
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17:30-17:45
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Closing and summary
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Japan:
Mr. Shinichi Takae (MHLW) Taiwan: Mr. Shang-ping Chen(NHIA) |
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18:00-
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Welcome reception * TKP Otemachi Conference room
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