Forum for Innovative Regenerartive Medicine

The 2nd
Asia Partnership Conference of
Regenerative Medicine AssociationsApril 11, 2019at Nihonbashi Life Science Building

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2nd APACRM(Asia Partnership Conference of Regenerative Medicine Associations)

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)