6/25~6/25『亞太經合會醫療器材法規協和研討會-提升優質決策之關鍵要素：優良審查規範』
行政院衛生署食品藥物管理局將於2010年6月25日，假君悅大飯店舉辦「亞太經合會醫療器材法規協和研討會-提升優質決策之關鍵要素：優良審查規範」(APEC Regulatory Harmonization on Medical Devices – Good Review Practices: A Key Enabler in Promoting Quality Decision-making)
本研討會是亞太經合會生命科學創新論壇(APEC LSIF)第一次舉辦以優良審查規範(Good Review Practice)為主題之研討會，同時正逢台灣國際健康暨醫療展；會中將邀請APEC藥物法規協和指導委員會(RHSC)委員、各國法規代表、以及醫療器材產業代表，說明醫療器材審查過程中之要項及考量要點。誠摯地歡迎產、官、學界醫療器材相關產業法規專業從業人員參加。
本次研討會酌收報名費，每名500元，由於名額有限，為免 向隅，敬請及早上網報名。
聯絡：醫材組 TEL：02-2322-4567 廖韋政(轉分機907)、盧妙月(轉分機914) ，E-mail：wcliao@cde.org.tw
時間 : 2010年6月25日 (星期五)，8:00-18:00
地點：台北君悅大飯店 凱悅廳 (台北市信義區松壽路二號三樓)
語言：英文、中文
指導單位：行政院衛生署
主辦單位：行政院衛生署食品藥物管理局
執行單位：財團法人醫藥品查驗中心
報名方式：線上報名 http://activity.cde.org.tw
恕不接受現場報名，報名費為每名500元(報到與會者，請須持本報到函通知入場)
議 程：
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Draft Agenda
June 25, 2010 (Friday)
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Time
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Topic
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Speaker
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8:00-8:30
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Registration
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8:30-8:40
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Welcoming Remarks
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Dr. Jaw-Jou Kang,
Director General, Food and Drug Administration, Chinese Taipei
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8:40-8:50
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Group Photo
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All Speakers and Moderators and VIP
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Moderator：Dr. Chun-Sheng Chien,
Deputy Director General, Food and Drug Administration, Chinese Taipei
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8:50-9:10
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APEC LSIF Contribution to Public Health (tentative)
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inviting, to be confirmed
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9:10-9:30
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Role of APEC LSIF in Promoting a more Strategic Approach to Regulatory Harmonization and Cooperation
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Mr. Mike Ward
RHSC Chair
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Session I: Views on Good Review Practice
Moderator：Dr. Herng-Der Chern,
Executive Director, Center for Drug Evaluation, Chinese Taipei
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9:30-10:00
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GHTF Medical Devices Regulation Model
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Mr. Michael Gropp, Vice President,
Global Regulatory Strategy,
Medtronic, Inc.
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10:00-10:20
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Break
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10:20-10:50
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Chinese Taipei
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Ms. Li-Ling Liu, Director,
Division of Medical Devices and Cosmetics,Food and Drug Administration, Chinese Taipei
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10:50-11:20
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to be confirmed
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Japan/PMDA
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11:20-11:50
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Difference between medical device and pharmaceutical, key regulatory consideration
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Ms. Lindsay Tao,
AHWP Representative
Corporate Director
Regulatory Government Affairs, Asia and Pacific, Johnson & Johnson
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11:50-12:20
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How do we use Essential Principal for Medical device specially for Class II low risk device in Japan (tentative)
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Mr. Hiroshi Ishikawa,
GHTF Steering Committee
Assistant to President, Toshiba Medical Systems Co.
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12:20-12:40
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Panel Discussion
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All Speakers
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12:40-13:40
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Lunch
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Session II: Current Approaches to GRPs
Moderator：Ms. Li-Ling Liu
Director, Division of Medical Devices and Cosmetics,Food and Drug Administration, Chinese Taipei
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13:40-14:30
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Presentation by CMR on outcomes of Workshop on Quality Decision-making
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CMR representative
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14:30-15:10
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Good Review Practices (GRP) at TPD
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Ms. Caroline Vanneste, Project Manager,
Good Review Practices Therapeutic Products Directorate,
Health Canada(to be confirmed)
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15:10-16:00
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(to be confirmed)
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Ms. Carole C. Carey, Director, International Staff
Center for Devices and Radiological Health,
Food & Drug Administration,
USA
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16:00-16:20
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Panel Discussion
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All Speakers
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16:20-16:40
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Break
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Session III: Emerging Technology and Products (TBD)
Moderator：Prof. Rong-Sen Yang,
Department of Orthopedics, National Taiwan University, Medical College and Hospital, Chinese Taipei
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16:40-17:20
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Nanotechnology (tentative)
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Dr. Subhas Malgan,
Deputy Director
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health,
Food & Drug Administration, USA
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17:20-17:50
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Development status of emerging products in Chinese Taipei (tentative)
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邵耀華主任(to be confirmed)
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17:50-18:00
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Closing Remarks
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Dr. Jaw-Jou Kang, Director General, Food and Drug Administration, Chinese Taipei
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業 務 導 覽
