Biotech China 2014
5th Annual Conference in Japan for Asian New Drug Development
Tower Hall Funabori
Tokyo Dome Hotel 1-3-61 Koraku Bunkyo-ku Tokyo 112-8562 Japan
Bunkyo-ku , Tokyo
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=24457&eventType=Meeting
   The fourth annual conference for Asian new drug development was held
   in Tokyo in April, 2010. Several issues about Asian development were
   discussed
   intensively from the sponsor’s and the regulatory reviewer’s point of
   view.

   For the fifth conference, the program committee has been joined by
   colleagues from East Asian countries – China, the Republic of Korea,
   Chinese Taipei, and Japan – who are actively involved in drug
   development in Asia. Nowadays, the practical organizations for Asian
   collaboration have
   been set up and several fruitful outcomes have been published. The
   more critical topics have been selected.

   Main topics are as follows:
   1) Oncology
   2) Pharmacogenomics
   3) Safety Reporting, Pharmacovigilance
   4) GCP Compliance and Inspection
   Several experts in drug development from China, the Republic of Korea,
   Chinese Taipei, and Japan will share their experiences and discuss how
   we
   can contribute to healthcare and the patients in Asia. We are also
   planning for opportunities for substantive discussion with Asian
   regulators including
   PMDA in order to develop new drugs which contribute to public health.

   Event Code:
   11302

Schedule of Presentations:

Tuesday, May 10, 2011
10:30:00 WELCOME AND OPENING REMARKS Hironobu Saito, Tatsuo Kurokawa, Ko Sekiguchi
11:00:00 KEYNOTE SESSION Noriaki Murao, Kyoichi Tadano
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 Junko Sato, Herng-Der Chern
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 Tomoko Okudaira, Patty Compton
Wednesday, May 11, 2011
09:15:00 SESSION 3 | GCP Inspection to Asian Sites Keiko Ebihara, Spring Wang
09:30:00 Session Description | GCP Inspection to Asian Sites | Inspection Experiences by EMA Zhixiang Shen, Alexander Honel
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 Sang-Goo Shin, Yoshiaki Uyama
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 Sang-Goo Shin, Yoshiaki Uyama
15:45:00 SESSION 5 | Ask the Asian Regulators Yoshihiko Ono, Hironobu Saito
16:00:00 Session Description | Ask the Asian Regulators Younglim Kim, Meir-Chyun Tzou, Yoshiaki Uyama
17:15:00 CLOSING REMARKS Hironobu Saito
4th Annual Pharma R&D Asia Congress
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