The 2nd Biomedical Innovation Workshop 2012
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The 2nd Biomedical Innovation Workshop 2012 Report
Biomedical Innovation Workshop 2012
Toward the Realization of Biomedical Innovation in Medical Devices
- Premise and Vision -
Today, we are in a position to give new direction to reform of the regulatory systems that govern medical devices and to operational improvements that will reflect the key features that distinguish medical devices from pharmaceuticals. We can take as a representative example The 5-Year Strategy for Promoting Biomedical Innovation, published June 6, 2012. Compared to pharmaceuticals, (1) medical devices have a wider variety, (2) they are modified and improved in shorter product cycles and (3) their risks and benefits are more closely associated with various medical procedures.
Looking back to past experience, it is remarkable that it could take over 5 years to introduce new regulations tailored to medical devices. In the U.S., a special committee of the Department of Health was formed in 1970, but new medical device regulations were not introduced until 1976. In the EU, it took 5 years following the "New Approach" standardization in the internal market before new medical device regulations were integrated, step by step, moving from more risky devices to the less risky.
In this workshop, against this backdrop of medical device regulation history in the EU and the U.S., we decided to provide a discussion arena for professionals in industry, government, and academia, as a basis for promoting biomedical innovation in medical devices. We will discuss (1) specific features of medical devices compared with other medical products, including pharmaceuticals, (2) possible methods and processes to expedite the introduction of new or improved devices, and (3) possible methods that would enhance the effective use of medical devices, and training issues.
| [Date] | Wednesday, July 25, 13:00-16:00 (Hall opens at 12:30) |
| [Venue] | Seminar Room (3rd floor)Map |
| [Hosted by] | UTokyo Policy Alternatives Research Institute (PARI) |
Program
| 12:30 --Registration-- | ||
|---|---|---|
| 13:00-13:15 --Opening Remarks-- | ||
| Prof. Ryozo Hayashi | Visiting Professor, Graduate School of Public Policy, the University of Tokyo | |
| 13:15-13:45 --Pre-Session-- | ||
| Mr. Shohei Nakano | Principal Researcher, Medical Device Strategy Institute in the Japan Association for the Advancement of Medical Equipment | |
| 13:45-15:25 --Panel Discussion-- | ||
| Panelists | ||
| Dr. Takeo Asano | Special Assistant to Director-General, Division for Promoting Biomedical Innovation at the Cabinet Secretariat | |
| Mr. Takeo Katakura | Project Researcher, Division of Biological Chemistry and Biologicals (super special district), National Institute of Health Sciences | |
| Prof. Dr., Ichiro Sakuma | Professor, Graduate School of of Engineering,the University of Tokyo/Vice Director for Center of Medical Device Review, Pharmaceuticals and Medical Devices Agency (PMDA) | |
| Ms. Mariko Mimura | Director and General Counsel for Novartis (lawyer) | |
| M.D. Ph D. Haruko Yamamoto | Director of the Division of Advanced Medicine and Promoting Clinical Trials, the National Cerebral and Cardiovascular Center | |
| 15:25-15:55 --Q&A-- | ||
| 15:55-16:00 --Closing Remarks-- | ||
| Moderator Chiaki Sato | Project Assistant Prof, Ph D., UTokyo PolicyAlternatives Research Institute (PARI), the University of Tokyo | |
*Admission Free.
*Language : Japanese
*Please note that this symposium has reached its full capacity and registration is closed. Walk-in registrations will not be accepted. Thank you very much.