It is our great pleasure to bring your attention to the 2011 APEC Multi-Regional Clinical Trials TOKYO Workshop, held in TOKYO, Japan, from November 1 to 2, 2011.
1.　The aim of TOKYO Workshop

The TOKYO Workshop succeeds “2010 APEC Multi-Regional Clinical Trials SEOUL Workshop” and keeps its aim of promoting Multi-Regional Clinical Trials in the Asia-Pacific region. As this year’s host nation, Japan sets TOKYO Workshop’s theme as “Seeking to promote Multi-Regional Clinical Trials in the APEC economies”. TOKYO Workshop is co-organized by Ministry of Health, Labour and Welfare, Pharmaceuticals and Medical Devices Agency, Society for Regulatory Science of Medical Products, and APEC Harmonization Center.

Prior to TOKYO Workshop, 4th China-Korea-Japan Director-General Meeting will be held also in Tokyo, chaired by MHLW/PMDA. The Director-General Meeting will discuss the tripartite cooperation in clinical studies and other items.

TOKYO Workshop, taking the outcome of the China-Korea-Japan Director-General Meeting into account, aims to further advance what SEOUL Workshop achieved. The Workshop invites speakers from the regulatory authorities, industries and academia in the APEC economies, to have the following 4 sessions of presentations and discussion.

  1. 1) DG meeting report symposium
  2. 2) Importance of Asia in global development strategy
  3. 3) Study design of Multi-Regional Clinical Trials
  4. 4) Case Studies (Oncology)

At the closing of the Workshop, panel discussion will be held and concluding remarks will be given to summarize the outcome.

2.　Date/Time

November 1 (Tue) and 2 (Wed), 2011

3.　Venue

Hitotsubashi Memorial Hall
National Center of Sciences Building
2-1-2, Hitotsubashi, Chiyoda-ku, 101-0003 TOKYO JAPAN

4. Workshop Organizers
Co-hosted by： Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Society for Regulatory Science of Medical Products (SRSM)
APEC Harmonization Center (AHC)
Supported by：Japan Pharmaceutical Manufacturers Association (JPMA)

5.　Registration

Online registration system is Japanese only. Please contact srsm-office@imic.or.jp if you like to make registration in English, executive office will tell you registration procedure.

  • Pre-Registration Dead line: 5 pm of October 21, 2011 Registration will be closed anytime when it reaches to the allocated number of registration (500 seats).
  • Registration fee: 20,000 YEN SRSM member: 15,000 YEN, SRSM young member: 7,000 YEN Only when we have vacancies, we can accept dive in entrance (Fees are: 30,000 YEN. For SRSM 25,000 YEN and SRSM young members 12,000 YEN)
  • Reception for all attendees will be held on Tuesday, in the evening of November 1st. If you would like to join this party, please pay the attendance fee 5,000 YEN with Pre- registration fee. (Dive in: 7,000 Yen)

6.　Program

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

7.　Inquiries

Executive Office of the Society for Regulatory Science of Medical Products
Shinanomachi Rengakan 35 Shinanomachi Shinjuku-ku
160-0016 TOKYO, JAPAN
Phone: +81-3-5312-1466 Fax: +81-3-5361-7091
E-mail: srsm-office@imic.or.jp