Date and time
Wednesday, April 11, 2018
12:30 ~ 18:00 (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
MC: Dr. Fusako Nishigaki (Vice Chair, Steering Committee of FIRM)
| 12:30-12:40 | Opening Remarks | Mr. Yuzo Toda (Chairman of FIRM) |
|---|---|---|
| 12:40-12:50 | Introduction of APACRM | Dr. Fusako Nishigaki (Vice Chair, Steering Committee of FIRM) |
| 12:50-14:05 | Keynote lecture: Three speakers from Academia and Regulatory authority scheduled | Chair: Dr. Yoshikazu Morishita (Chair, Public Affairs Committee of FIRM) |
| 12:50-13:15 | Manufacturing Technologies for Allogeneic Stem Cell Therapies. | Dr. Steve Oh (Bioprocessing Technology Institute, A*STAR) |
| 13:15-13:40 | Development of Regenerative Therapy for Advanced Heart Failure | Dr. Yoshiki Sawa (Director, The Japanese Society for Regenerative Medicine) |
| 13:40-14:05 | Regenerative Medicine Product Regulations in Japan -Enhancing the development of Advanced Therapy- |
Dr. Kiyohito Nakai (Ministry of Health, Labour and Welfare) |
| 14:05-14:25 | <Break> | |
| 14:25-16:25 | Presentation from Industrial association | Chair: Mr. Hajime Miyamoto (Vice Chair, Steering Committee of FIRM) |
|---|---|---|
| 14:25-14:45 | Status-sharing presentation by each participant on market and regulatory environment surrounding Regenerative Medicine and Cell/Gene therapy | Mr. Ning Wu, CMBA (China) |
| 14:45-15:05 | Dr. Oscar K. Lee, BPIPO (Taiwan) | |
| 15:05-15:25 | Dr. Bryan Choi, GSRAC & CARM (Korea) | |
| 15:25-15:45 | Mr. Balu Narasimhan Manohar, ABLE (India) | |
| 15:45-16:05 | Mr. Wong Kum Cheun, SAPI (Singapore) | |
| 16:05-16:25 | Mr. Masanobu Kimura, FIRM (Japan) |
| 16:25-16:45 | <Break> | |
|---|---|---|
| 16:45-17:45 | Round table | Chair: Mr. Kunihiko Suzuki (Vice Chair of FIRM) |
| Round table by all participants toward a cooperative framework for regulation harmonization over the region | Speakers: Industrial Association Mr. Ning Wu, CMBA (China) Mr. Ching-Lung Hu, BPIPO (Taiwan) Dr. Bryan Choi, GSRAC & CARM (Korea) Mr. Balu Narasimhan Manohar, ABLE (India) Mr. Wong Kum Cheun, SAPI (Singapore) Mr. Masanobu Kimura, FIRM (Japan) Speakers: Regulatory Authority Dr. Jeewon Joung, Korea FDA (Korea) Dr. V. G. Somani, CDSCO (India) Dr. Hsin Jung Lee, CDE (Taiwan) Dr. Yoshiaki Maruyama, PMDA (Japan) |
|
| 17:45-17:55 | Summary | Mr. Kunihiko Suzuki (Vice Chair of FIRM) |
| 17:55-18:00 | Closing Remarks | Dr. Nobuyuki Osakabe (Vice Chair of FIRM) |
| 18:30-20:00 | <Reception> | |
CMBA (China Medical Biotech Association), CARM (The Council for Advanced Regenerative Medicine), ABLE (Association of Biotechnology Led Enterprises), SAPI (Singapore Association of Pharmaceutical Industries), BPIPO (Biotechnology & Pharmaceutical Industries Promotion Office, Ministry of Economic Affairs), CDSCO (Central Drugs Standard Control Organization), CDE (Center for Drug Evaluation)