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Special DIA Japan 2014 Medical Device Pass: Attend [V6-S6] and Stay through Closing Sessions

Nov 18 2014 11:00AM - Nov 18 2014 6:30PM | Tokyo Big Sight 3-11-1 Ariake Koto-ku Tokyo 135-0063 Japan

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11:00-12:30 SESSION 6  [V6-S6] ~ New Relationship of Drugs and Medical Devices Will Open up the Future of the Health Care

Even in the therapeutic area where medical treatment by drugs has been traditionally common the treatment by medical devices has started for the patients who are resistant to treatment by drugs.

Further such medical devices like PDT Laser and Vascular Embolization Beads which increase effectiveness of medical treatment when used together with drugs have been used for treatment of certain cancer which has been traditionally difficult to treat.

As above, beyond combination products such as drug eluting stent the innovative combined usage of drug and medical devices has opened new phase of opportunities for new medical treatment.

As combined usage of drugs and medical devices is getting more complex how to evaluate the clinical benefit of such combined products is also getting complex.

Since the criteria of clinical evaluation is different between drugs and medical devices because of their product characteristics it is important to start discussion for clinical evaluation criteria and methodology for new medical treatment by combined usage of drugs and medical devices.

Koji Ikeda, PhD
Professor, Clinical Research
Innovation and Education Center
Tohoku University Hospital

Presentation 1
Isao Tsuchii
Business Operator
Green Field

Presentation 2

Presentation 3
Yuka Suzuki, PhD
Director of Office of Medical Devices II
Pharmaceuticals and Medical Devices Agency (PMDA)

Panel Discussion
All speakers above

12:30-13:30 LUNCH

13:50-14:50 SPECIAL SESSION ~ Medical Contributions With A New Perspective That Transcends Boundaries

Kazuhiko Mori
Director, Evaluation and Licensing Division
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare

Robot Suit HAL is the world’s first cyborg-type robot developed by full use of Cybernics which is a new academic field (fused and interdisciplinary technology related to human, machine and information) consisting of neuroscience, motor physiology, robotics, information technology, behavior science, system integration technology, law, ethics and business management.

HAL enhances and strengthens the limb motion of its wearer by detecting the weak bioelectrical signals through the body from the brain which generates the nerve signal to control the musculoskeletal system and promotes treatment for functional improvement, regeneration and acquisition for disabled people by spinal cord injury or stroke and also supports self-independent motion like activity of daily life and nursing-care motion when care-giver lifts patients.

HAL has obtained CE marking, the certificate for all EU countries, as the first robotic therapeutic device and in Germany, application of public workers’ compensation insurance to cover the costs of using HAL for medical treatment has been implemented.

Now, medical contributions with a new perspective that transcends boundaries are accelerating by research and development in the field of new combined therapies such as HAL therapy with regenerative medicine and/or pharmaceuticals.

Yoshiyuki Sankai, PhD
Graduate School of Systems & Information Engineering
The University of Tsukuba
President and CEO


15:00-15:30 COFFEE BREAK

15:30-17:00 ROUND TABLE International ~ What are Expectations for “Adaptive Licensing”?

Kazuhiko Mori
Director, Evaluation and Licensing Division
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and Welfare

Yoshihiko Ono
Executive Director, Head of Regulatory Affairs
Japan Development, MSD K.K.

Adoptive Licensing (AL) is getting much attention as a system for improving access to new medicines or medical technologies with high medical needs. The EMA has already considered Medicine’s Adaptive Pathways (MAPs) or Medicine’s Adaptive Pathways to Patients (MAPPs) and launched a pilot project. In Japan, the Act on the Safety of Regenerative Medicine was enacted, permitting early approval of tissueengineered medical products, which is thought to be a kind of AL.

When institutionalizing AL, how far efficacy and safety should be ensured in order to permit access to medicines based on limited data, as well as how to assess the risks and benefits, are all important issues.

In this session, we’ll grasp the benefits and the problems of AL and discuss the expected system.

Implementation of Adaptive Licensing in Europe
Francesco Pignatti, MD
Head of Oncology, Haematology, Diagnostics
European Medicines Agency

Perspective on the Regulatory Schema of the Adaptive Licensing for Pharmaceuticals
Daisaku Sato, PhD
Office Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Device Agency (PMDA)

Industry Perspective on the Future Regulatory System for Drug Approval
Hiromichi Shirasawa, MD
Vice President and Executive Officer, Head of Japan Development

17:00-17:10 SHORT BREAK

17:10-18:25 PMDA TOWN HALL

Tomiko Tawaragi
Chief Safety Officer
Pharmaceuticals and Medical Device Agency (PMDA)

Hiroshi Watanabe, MD, PhD
Deparment of Clinical Pharmacology & Therapeutics
Hamamatsu University School of Medicine

This session is provided for you to discuss with Pharmaceuticals and Medical Devices Agency (PMDA) members on your interests. To make this session really meaningful, we welcome your active participation. See you at the session!


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