独立行政法人医薬品医療機器総合機構(Pharmaceuticals and Medical Devices Agency))
衛生福利部食品薬物管理署(Taiwan Food and Drug Administration)
財團法人醫藥品查驗中心(Center for Drug Evaluation)
【Joint Session】
MC:FUKUDA Eriko, International Cooperation Officer, PMDA
11:00-11:50
Registration
11:50-12:00
Photo Session
12:00-12:10
Opening Remarks (5 min each)
-HANAKI Izuru, Senior Executive Director, Japan-Taiwan Exchange Association
-Ching-Hung Lin, Deputy Secretary General, Taiwan-Japan Relations Association
12:10-12:50
Keynote speeches-Regulatory updates (40 min)
-Regulatory updates in Japan(15 min)
UZU Shinobu, Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA)
-Regulatory updates in Taiwan(15 min)
Shou-Mei Wu, Director-General, Taiwan Food and Drug Administration (TFDA)
-Q & A, (10min)
【Pharmaceuticals)】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
12:50-13:35
Regulatory challenge against COVID-19 (45 min)
Moderator:Chien-Liang Lin, Director, Division of Medicinal Products, TFDA
-Regulatory Challenge against COVID-19(15 min)
MATSUKURA Yuji, Deputy Director, Office of International Regulatory Affairs, MHLW
-Measures for accelerating vaccine development and challenges of clinical trials(15 min)
Mei-Chen Huang, Section Chief, Division of Medicinal Products, TFDA
-Q & A, (15min)
【Health Insurance)】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
13:35-14:20
Health Insurance (45 min)
Moderator: NAGAOKA Akihiro, Chairman, Asia Committee International Affairs, Japan Pharmaceutical Manufacturers Association (JPMA)
-Drug Pricing System in Japan (15 min)
MIYASHITA Masaya, Section Chief of New Drug Pricing Section in Economic Affairs Division Health Policy Bureau, MHLW
-Updates on Drug Reimbursement Model of Taiwan's NHI System (15 min)
Hsueh-Yung (Mary) Tai, Director of the Medical Review and Pharmaceutical Division of the National Health Insurance Administration (NHIA)
-Q & A, (15min)
【Medical Devices】
MC:FUKUDA Eriko, International Coordination Officer, PMDA
14:20-15:05
Recent Regulatory Challenge in Medical Devices (45 min)
Moderator: Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA
-The regulatory perspective of reviewing COVID-19 diagnostic test kits (15 min)
YABANA Naoyuki, Director, Office of In Vitro Diagnostics, PMDA
-The Principle of Reviewing Medical Device Cybersecurity (15 min)
Chun-Jen Chien, Technical Specialist, Division of Medical Devices and Cosmetics, TFDA
-Q & A, (15min)
15:05-15:50
QMS -Utilization of MOC (45min)
Moderator:KUSAKABE Tetsuya, International Cooperation Officer, PMDA
-Current Situation of Utilizing MOC
FUJISAWA Hiroshi, Inspector, Office of Manufacturing Quality and Vigilance for Medical Devices, PMDA (15min)
-QSD Review and Utilization of MOC(15min)
Szu-Yu Lee, Section Chief, Division of Quality Compliance and Management, TFDA
-Q & A, (15min)
【Joint Session】
MC:FUKUDA Eriko, International Coordination Officer, PMDA