●くろまる Presented Powerpoint (in pdf)
Thu. October 12
Chair: Mr. Shuuichi Kishida, Senior Executive Director, PMDA
13:30〜13:45
Opening Remarks
Dr. Tatsuo Kurokawa, Councilor, Minister's Secretariat, MHLW (Japan)
13:45〜14:15
The Impact of Global Development: a US FDA Perspective
Dr. Murray M. Lumpkin, Deputy Commissioner, FDA (USA)
14:15〜14:45
Global Development of Drugs and Co-operation among Asian Economies
Dr. Chi-Chou Liao,
Director General, Bureau of Pharmaceutical Affairs,
Department of Health (Chinese Taipei)
Department of Health (Chinese Taipei)
14:45〜15:15
Role of Japan and Asian Countries in the Global Pharmaceutical Development
Mr. Akira Miyajima, Chief Executive, PMDA (Japan)
15:15〜15:45
Coffee Break
Chair: Mr. Akira Kawahara, Chief Safety Officer, PMDA
15:45〜16:15
Recent Development of ICH GCG
Dr. Minoru Kubota, Chairman, ICH Project Committee, JPMA (Japan)
16:15〜16:45
The Continuing History of the Safety of Medicines
Prof. Sir Alasdair M. Breckenridge, Chairman, MHRA (UK)
16:45〜17:15
Combination Products and Asia Regional Medical Device Regulatory Harmonization
Mr. Michael B. Gropp,
Vice President, Global Regulatory and Public Policy,
Abbott Vascular, Brussels (Belgium)
Abbott Vascular, Brussels (Belgium)
19:00〜21:00
Reception
Fri. October 13 AM
Session and Panel Discussion on Global Development in Asia
Chair: Dr. Toshiyoshi Tominaga,
International Planning Director (Pharmaceutical Affairs),
Minister's Secretariat, MHLW (Japan)
Minister's Secretariat, MHLW (Japan)
9:00〜9:20
Global Development in Asia: a PhRMA Perspective
Mr. Harrison C. Cook, Co-chair, JTC, PhRMA (USA)
9:20〜9:40
Global Develoment in Asia - a JPMA perspective -
Mr. Hironobu Saito,
Senior Vice Director, Clinical Development Department &
Asia Drug Development and Registration Section,
New Drug Development Division, Sankyo Co., Ltd. (Japan)
Asia Drug Development and Registration Section,
New Drug Development Division, Sankyo Co., Ltd. (Japan)
9:40〜10:00
Global Development in Asia: The Singapore Perspective
Dr. John Lim, Chief Executive Officer, HSA (Singapore)
10:00〜10:20
Global Clinical Trials in Korea
Dr. In-Sook Park,
Deputy Director, Narcotic and Neuropharmacological
Drug Team, Department of Drug Evaluation, KFDA (Korea)
Drug Team, Department of Drug Evaluation, KFDA (Korea)
10:20〜10:50
Coffee Break
10:50〜11:10
Global Development in Chinese Taipei
Dr. Herng-der Chern, Executive Director, CDE (Chinese Taipei)
11:10〜11:30
Global Development: Japanese Efforts and Views
Mr. Kazuhiko Mori, Associate Center Director, PMDA (Japan)
11:30〜12:20
Panel Discussion
12:20〜14:20
Lunch
Fri. October 13 PM
Chair: Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)
14:20〜14:50
EMEA's Views on Global Development
Mr. Thomas Lönngren, Executive Director, European Medicines Agency (EMEA)
14:50〜15:20
ASEAN Harmonization
Dr. Yuppadee Javroongrit, Thai FDA (Thailand)
15:20〜15:50
Coffee Break
15:50〜16:20
Expectations of Asian Collaboration and Contribution to New Medicines
Mr. Kazuhiko Nakajima, Chairperson of Drug Evaluation committee, JPMA (Japan)
16:20〜16:50
Summary Report APEC 2006
Dr. Satoshi Toyoshima, Executive Director, PMDA (Japan)
16:50〜17:00
Closing Remarks
Mr. Toshiro Nakagaki,
Director, Evaluation and Licensing Division,
Pharmaceutical and Food Safety Bureau, MHLW (Japan)
Pharmaceutical and Food Safety Bureau, MHLW (Japan)
●くろまる Symposium scenes Click here >>
●くろまる Questionnaire Result Click here >>
■しかくPharmaceuticals and Medical Devices Agency
■しかくMinistry of Health, Labour and Welfare
Secretariat of APEC 2006 PH