2011年APEC 多地域共同臨床試験 東京ワークショップ TOP > プログラム
プログラム
 
Day 1, November 1
10:00-10:10
Welcoming Remarks
Speakers:
Dr. Yoshinobu Hirayama(MHLW)
Dr. Tatsuya Kondo (PMDA)
10min.
10:00-10:10
10:10-10:30
MRCT Roadmap and Recommendation from Last Year's Workshop
Speaker:
Dr. Justina Molzon (APEC RHSC Training Subcommittee)
20min.
10:10-10:30
10:30-12:30
Session 1:DG meeting report symposium I
Administrators' Report
Chair: Mr.Naoyuki Yasuda (MHLW)
3Speakers:
Japan：Mr. Naoyuki Yasuda (MHLW)
Korea：Dr. Sun-Hee Lee (KFDA)
China：Mr. Zhang Wei (SFDA)
25min.
25min.
25min.
10:30-10:55
10:55-11:20
11:20-11:45
Discussant
USA：Dr. Justina Molzon (FDA)
25min.
11:45-12:10
Discussion & Summary of the session
20min.
12:10-12:30
12:30-13:30
Lunch
60min.
12:30-13:30
13:30-15:00
Session2:DG meeting report symposium II
Ethnic Factor Research
Chair:Dr.Masahiro Tohkin (Nagoya City University)
3Speakers:
Dr. Masahiro Tohkin (Nagoya City University)
Prof. Cui Yimin (Peking University First Hospital)
Dr. In-Jin Jang (Seoul National University)
25min.
25min.
25min.
13:30-13:55
13:55-14:20
14:20-14:45
Discussion & Summary of the session
15min.
14:45-15:00
15:00-15:30
Intermission
30min.
15:00-15:30
15:30-17:50
Session 3: Importance of Asia in global development strategy
Chair: Dr. Ling Su (Novartis)
5Speakers:
Dr. Jerry Stewart (Pfizer)
Dr. Yoshiaki Uyama (PMDA)
Dr. Tomas Salmonson (EMA)
Mr. Haruhisa Hirosaki (Astellas)
Dr. Thomas R. Verhoeven (Eli Lilly)
25min.
25min.
25min.
25min.
25min.
15:30-15:55
15:55-16:20
16:20-16:45
16:45-17:10
17:10-17:35
Discussion & Summary of the session
15min.
17:35-17:50
Day 2, November 2
09:30-12:00
Session 4:Study Design
Chair Dr. MasahiroTakeuchi (Kitasato University)
Chair's Report
2010 MRCT Workshop & Introduction
10min.
09:30-09:40
5Speakers:
Ms. Madoka Takeuchi(Harvard School of Medicine), presenting on behalf of Dr. Lee-Jen Wei(Harvard School of Public Health)
Dr. Jim Hung(FDA)
Ms. Yuki Ando (PMDA)
Dr. Yao Chen (Beijing University)
Dr. Kihito Takahashi (GSK)
25min.
25min.
25min.
25min.
25min.
09:40-10:05
10:05-10:30
10:30-10:55
10:55-11:20
11:20-11:45
Discussion & Summary of the session
15min.
11:45-12:00
12:00-13:00
Lunch
60min.
12:00-13:00
13:00-15:05
Session 5:Case Studies
Chair: Dr. Yasuhiro Fujiwara, (National Cancer Center Hospital)
Chair's Report
2010 MRCT Workshop & Introduction
Topic: Oncology
10min.
13:00-13:10
4Speakers:
Ms. Yang Zhimin (CDE, SFDA)
Dr. Hanlim Moon (GSK)
Dr. Junichi Hashimoto (Pfizer)
Dr. Chih-Hsin James Yang (National Taiwan University)
25min.
25min.
25min.
25min.
13:10-13:35
13:35-14:00
14:00-14:25
14:25-14:50
Discussion & Summary of the session
15min.
14:50-15:05
15:05-15:30
Intermission
30min.
15:05-15:30
15:30-17:00
Session 6:Panel Discussion
Chairs: Dr.Toshiyoshi Tominaga (PMDA) and Dr.Masaru Iwasaki (Yamanashi University)
PartⅠ: Session Report
Speakers:
Dr. Toshiyoshi Tominaga (PMDA)
Dr.Masaru Iwasaki (Yamanashi University)
20min.
15:30-15:50
PartⅡ:Panel Discussion
Panelists:
Dr. Masahiro Takeuchi (Kitasato University)
Dr.Yasuhiro Fujiwara (National Cancer Center Hospital)
Dr. Yoshiaki Uyama (PMDA)
Dr. Ling Su (Novartis)
Dr. Gyu-Han Chae (KFDA)
Ms. Dong Jiangping (CDE, SFDA)
70min.
15:50-17:00
17:00-17:10
Concluding Remarks:Direction found in this WS
Speaker:
Dr. Hideo Utsumi (PMDA)
10min.
17:00-17:10
17:10-17:20
Closing Remarks
Speaker:
Dr. Yutaka Kirino (Society for Regulatory Science of Medical Products, Japan)
10min.
17:10-17:20
 
Meeting Adjourned