※ Celebrating MHLW's and PMDA's New International Strategic Plans concluded.
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Celebrating MHLW's and PMDA's New International Strategic Plans
“Toward further promotion of regulatory science and global capacity building”
Pharmaceuticals and Medical Devices Agency (PMDA) has succeeded in shortening the review period for medical products to the world’s top standard through its 1st and 2nd Mid-term Plan Periods (FY 2004 to 2013). PMDA has been highly evaluated internationally for this and other achievements, and now positioned to contribute more to the world. In order to respond to the domestic and global expectations, PMDA announced its strategic plan titled “PMDA International Strategic Plan 2015” on June 26, 2015. Ministry of Health, Labour and Welfare (MHLW) also announced its strategic plan for international regulatory harmonization on the same day. To mark the launch of both strategic plans, PMDA held the meeting entitled Celebrating MHLW’s and PMDA’s International Strategic Plans “Toward further promotion of regulatory science and global capacity building”, which will be cohosted by MHLW.
The meeting addressed the importance of promoting international regulatory harmonization by implementing these strategic plans, and of further reinforcing cooperation with countries in Asian, European and American regions. Leading regulators from the world as well as industry representatives and those who promote pharmaceutical research and development in Japan were invited to give presentations for fruitful discussion on future forms of international cooperation.
Date
Thursday, September 3, 2015. 13:00-17：40
Venue
Nissho Hall (Toranomon 2-9-16, Minato-ku, Tokyo 105-0001, Japan)
Access map is only available in JapaneseHost
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Registration
Click here to register (registration deadline: August 27, 2015).
This meeting is free of charge for participation.
Press registration will be announced at a later date.
Program
13:00 - 13:10
Opening Remark from MHLW
Mr. Katsunori Hara
Vice-Minister for policy coordination
Ministry of Health, Labour and Welfare (MHLW)
13:10 - 13:30
International Regulatory Harmonization Strategy (Regulatory Science Initiative: RSI）
Mr. Yuji Kanda
Director General
Pharmaceutical and Food Safety Bureau
MHLW
13:30 - 13:40
Greeting
Dr. Tatsuya Kondo
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA)
13:40 – 14:00
Introduction to PMDA’s International Strategic Plan 2015
Dr. Toshiyoshi Tominaga
Associate Executive Director for International Programs
PMDA
14:00 - 15:10
Celebrating MHLW/PMDA New International Strategic Plans
Dr. Boonchai Somboonsook
Secretary-General
Thai FDA, Thailand
Mr. Zamane bin Abdul Rahman
Chief Executive of Medical Device Authority
Ministry of Health, Malaysia
Aligning International Regulatory Goals Through Innovation and Collaboration
A/Prof. John C W Lim
Deputy Director of Medical Services (Industry & Research Matters)
Ministry of Health, Singapore
15:10 - 15:40
Break
15:40 - 16:25
FDA Medical Products Through the Lens of Precision
Dr. Robert Califf, MD
Deputy Commissioner for Medical Products and Tobacco
U.S.FDA, U.S.A.
Convergence through Regulatory Science - thinking Globally and Collaboratively
Ms. Emer Cooke
Head of International Affairs
European Medicines Agency, EU
16:25 - 16:50
AMED: Missions and Perspectives
Dr. Makoto Suematsu
Japan Agency for Medical Research and Development
Mr. Masafumi Nogimori
President
Federation of Pharmaceutical Manufacturers' Associations of Japan (FPMAJ)
Expectations to the international strategic plans from an industry perspective
Mr. Fumio Suzuki
Vice Chairman
The Japan Federation of Medical Devices Associations
17:35 - 17:40
Closing Remark
Mr. Masatoshi Narita
Deputy Director-General for Minister's Secretariat
MHLW