| Day 1 - Friday, November 1st Understanding the rules of the game | |||
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| 12:30 | Doors Open | ||
| 13:30 | Opening Remarks | Yasushi Sakata Center for Advanced Medical Engineering and Informatics Osaka University |
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| Market, QA & RA, Reinbursement | Session Chairs Kodama Junko, Edwards Life Sciences LLC Kuniko Shoji, Kanagawa Prefectural University of Health and Welfare / Medical Device Center |
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| 13:35 | Medical device market in the US: Why US market? | Takashi Suzuki, PhD Japan Association for the Advancement of Medical Equipment |
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| 14:10 | QA & RA in US: What are the barriers and challenges? | Jiro Hirai Olympus Terumo Biomaterials Corporation. |
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| 14:45 | Insurance system in US: What is the difference between US and Japan? | Toshifumi Hayashi Edwards Lifesciences LLC |
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| 15:20 | Tea Break | ||
| Invited Session from US - 1 | Session Chairs Kodama Junko, Edwards Life Sciences LLC Kuniko Masako, Kanagawa Prefectural University of Health and Welfare / Medical Device Center |
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| 15:40 | Distribution, UDI(Unique Device Identification), GPO(Group Purchasing Organizations) |
Dennis Black UDI Program Director Global Regulatory Operations BD |
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| 17:20 | Q&A and Panel Discussions | ||
| 18:00 | Networking | ||
| Day 2 - Saturday, November 2nd Lerning from the real medical device business in US | ||
|---|---|---|
| 09:30 | Doors Open | |
| Invited Session from US - 2 | Session Chair Shohei Nakano, Japan Association for the Advancement of Medical Equipment Takahiro Haruyama, Globizz Corporation |
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| 10:00 | How to go into the market of medical devices in US? | Takahiro Haruyama Globizz Corporation |
| 10:30 | Market access hot topics - Reimbursement - Coverage - Coding - Payment |
Eric Lam PhD, Director Hull Associates |
| 12:00 | Q&A and Panel Discussions | |
| 12:30 | Lunch Break | |
| Learning from real-world experience | Session Chair Shohei Nakano, Japan Association for the Advancement of Medical Equipment Yoshiyuki Taenaka, Center for Advanced Medical Engineering and Informatics, Osaka University |
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| 13:30 | Market entry for medical device in Japan then to US | Makoto Nishiuchi Asahi Intecc Co., LTD |
| 14:00 | Getting into US medical ICT market | Teppei Sakano Allm Inc. |
| 14:30 | First case of using Harmonizing By Doing (HBD) frame for US market | Seigo Nakano Terumo Corporation |
| 15:00 | Q&A and Panel Discussions | |
| 15:30 | Closing Remarks | Yoshiyuki Taenaka Center for Advanced Medical Engineering and Informatics, Osaka University |