Tuesday, May 10, 2011 |
10:30:00 |
WELCOME AND OPENING REMARKS |
Ko Sekiguchi, Tatsuo Kurokawa, Hironobu Saito
|
11:00:00 |
KEYNOTE SESSION |
Kyoichi Tadano, Noriaki Murao
|
11:30:00 |
KEYNOTE 1 | Update of International Collaboration | Taiwan Point of View |
Chao-Yi Wang
|
12:00:00 |
KEYNOTE 2 | Asia Development in the Frame of Global Development |
Yosuke Tanaka
|
13:30:00 |
SESSION 1 | Oncology Part 1 | Asian Leadership for Regionally Common Cancers |
Yosuke Tanaka
|
14:00:00 |
Session Description | Oncology – Part 1 | Asian Leadership for Regionally Common Cancers |
Yung-Jue Bang
|
14:15:00 |
Regulatory Support and Consideration in the Design of Regional Clinical Trials of Oncology: Taiwan’s Experience |
Herng-Der Chern
|
14:30:00 |
Experience on Regional Clinical Development in Oncology |
Toshihiko Doi
|
15:00:00 |
Proposal for Regional Clinical Development in Oncology |
Hanlim Moon
|
15:50:00 |
SESSION 2 | Oncology – Part 2 | Safety Reporting in Clinical Trials |
Herng-Der Chern, Junko Sato
|
16:05:00 |
Session Description | Oncology – Part 2 | Safety Reporting in Clinical Trials |
|
16:15:00 |
Insuring the Safety of the Patient | Effective Execution of Oncology Trials |
Patty Compton, Tomoko Okudaira
|
Wednesday, May 11, 2011 |
09:15:00 |
SESSION 3 | GCP Inspection to Asian Sites |
Spring Wang, Keiko Ebihara
|
09:30:00 |
Session Description | GCP Inspection to Asian Sites | Inspection Experiences by EMA |
Alexander Honel, Zhixiang Shen
|
10:00:00 |
Current Situation and Challenges in GCP Inspection in Global Clinical Trials |
Emiko Kondo
|
10:30:00 |
Company Audit for Asian Sites and Japan Sites |
Kiyomi Hirayama
|
11:25:00 |
SESSION 4 | Importance of Pharmacogenomics in the East Asian Population |
Yoshiaki Uyama, Sang-Goo Shin
|
11:55:00 |
Session Description | Importance of Pharmacogenomics in the East Asian Population |
|
12:00:00 |
Korean Activities to Realize PGx-based Medicine |
Jae-Gook Shin
|
12:15:00 |
Activities | Progress | Stevens-Johnson Syndrome |
|
12:30:00 |
Usefulness of Pharmacogenomics in Japanese Population Based on Latest Scientific Knowledge |
Junichi Azuma
|
12:40:00 |
Omics Project in PMDA |
Yasuto Otsubo
|
14:05:00 |
Importance of Pharmacogenomics in the East Asian Population |
Yoshiaki Uyama, Sang-Goo Shin
|
15:45:00 |
SESSION 5 | Ask the Asian Regulators |
Hironobu Saito, Yoshihiko Ono
|
16:00:00 |
Session Description | Ask the Asian Regulators |
Yoshiaki Uyama, Meir-Chyun Tzou, Younglim Kim
|
17:15:00 |
CLOSING REMARKS |
Hironobu Saito
|