Date and time
Thursday, April 11, 2019
9:30 ~ 18:20 (Conference), 18:30 ~ (Reception) (JST)
(Closed, FIRM Member Only)
Location
Nihonbashi Life Science Building,
2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan, http://www.nihonbashi-lifescience.jp/en/
Conference; 2nd Floor Conference Room
Reception; 10th Floor
Sponsor
FIRM (Forum for Innovative Regenerative Medicine)
Program (Draft)
MC: Dr. Fusako Nishigaki (Chair, International Affairs Committee, Vice Chair, Steering Committee of FIRM)
● Updated 2019.03.08
| 9:30-9:35 | Opening Remarks | Yuzo Toda (Chairman of FIRM) |
|---|---|---|
| 9:35-9:45 | Introduction | Fusako Nishigaki |
| 9:45-10:15 | Keynote lecture | MC:Hiroyuki Ishida, Toshihiro Maeda (International Affairs Committee of FIRM) |
| 9:45-10:15 | Yoshiaki Maruyama, PMDA (Japan) | |
| 10:15-11:15 | Presentation from Industrial association Part 1 | MC: Hiroyuki Ishida, Toshihiro Maeda |
| 10:15-10:45 | Ning Wu, CMBA (China) | |
| 10:45-11:15 | Bryan Choi, SCRM & CARM (Korea) | |
| 11:15-11:30 | <Photo session> 2nd Floor Conference Room | |
| 11:30-12:45 | <Lunch> 3rd Floor Conference Room ### | |
| 12:45-14:45 | Presentation from Industrial association Part 2 | MC:Hiroyuki Ishida, Toshihiro Maeda |
|---|---|---|
| 12:45-13:15 | Status-sharing presentation by each participant on market and regulatory environment surrounding Regenerative Medicine and Cell/Gene therapy | Balu Narasimhan Manohar, ABLE (India) |
| 13:15-13:45 | TBD, Taiwan (BPIPO) | |
| 13:45-14:15 | Wong Kum Cheun, SAPI (Singapore) | |
| 14:15-14:45 | Yoshitsugu Shitaka, FIRM (Japan) | |
| 14:45-15:05 | <Break> | |
| 15:05-18:05 | Round table | MC:Fusako Nishigaki |
| 15:05-15:45 | Round table 1 Acceptance criteria of allogeneic MSC |
Chair: Yoshie Tsurumaki Speakers: Industrial Association Speakers: Regulatory Authority |
| 15:45-16:25 | Round table 2 Acceptability of the foreign non-clinical data on a case of allogeneic MSC |
Chair: Kunihiko Suzuki Speakers: Industrial Association Speakers: Regulatory Authority |
| 16:25-16:45 | <Break> | |
| 16:45-17:25 | Round table 3 The sharing of foreign clinical trial data |
Chair: Yoshie Tsurumaki Speakers: Industrial Association Speakers: Regulatory Authority |
|---|---|---|
| 17:25-18:05 | Round table 4 The quality control and traceability of the raw materials including the supplier |
Chair: Masayuki Nomura Introduction: Yoji Sato (Head of Division of Cell-Based Therapeutic Products, NIHS) Speakers: Industrial Association Speakers: Regulatory Authority |
| 18:05-18:15 | Summary | Yoshitsugu Shitaka (Vice Chair of FIRM) |
| 18:15-18:20 | Closing Remarks | Kunihiko Suzuki (Vice Chair of FIRM) |
| 18:30-20:00 | <Reception> | |
CMBA (China Medical Biotech Association), CARM (The Council for Advanced Regenerative Medicine), SCRM (Strategic Center for Regenerative Medicine), ABLE (Association of Biotechnology Led Enterprises), BPIPO (Biotechnology & Pharmaceutical Industries Promotion Office, Ministry of Economic Affairs), SAPI (Singapore Association of Pharmaceutical Industries)