{"id":326,"date":"2015-01-01T15:46:33","date_gmt":"2015-01-01T06:46:33","guid":{"rendered":"http:\/\/www.waseda.jp\/inst\/ori\/?p=326"},"modified":"2019-05-28T15:29:51","modified_gmt":"2019-05-28T06:29:51","slug":"institute-for-medical-regulatory-science","status":"publish","type":"post","link":"https:\/\/www.waseda.jp\/inst\/ori\/other-en\/2015\/01\/01\/326\/","title":{"rendered":"Institute for Medical Regulatory Science"},"content":{"rendered":"
\"Field\"<\/a>

Field<\/p><\/div>\n

Director : Mitsuo UMEZU
\nProfessor,Faculty of Science and Engineering<\/p>\n

Research theme<\/h3>\n

Creation of a secure and safe society through a bird\u0081’s-eye research project with a non-clinical, evaluation-type recycling model of advanced medical equipment at its core.<\/p>\n

Overview of research<\/h3>\n

This institute creates \u201cmedical regulatory science (RS)\u201d which has a new integrated systems science that combines rapidly-progressing natural sciences such as medicine, science and engineering, pharmacy, etc. with diversifying humanities and social sciences in order to realize the university research initiative of Waseda University \u201cRealization of safety and security and improvement of the quality of life in the 21st century\u201d. The objective of this institute is to establish safe and expedient clinical application of highly advanced medical technologies for patients\u2019 peace of mind.
\nThe RS concept proposed by Dr. Mitsuru Uchiyama in 1987 is a world-class concept and has the \u2018regulatory science\u2019 aspect that gives a scientific basis to regulatory policies and the \u2018evaluation science\u2019 aspect which is different from existing basic science and applied science. However, although subsequently RS has received attention in many fields, the interpretation of the concept is not uniform and its academic structure as a science has still not been formed. After the Great East Japan Earthquake in March 2011, the 4th Science and Technology Basic Plan of Japan announced in August the integrated promotion of \u201cscience, technology and innovation (STI) policies\u201d positioning life innovation as a major pillar to prepare for the hiper-gerontological society to come. This plan also indicated the importance of RS taking into account the Fukushima Daiichi Nuclear Power Station accident. To realize the academic structure of RS as a science for constructing new relationships between ceaselessly progressing science and technology is the most important issue that has been assigned to us.
\nWe define medical RS as \u201can evaluation, forecasting, and decision-making science\u201d for harmonizing and coordinating advanced sciences and technologies related to health and medical care in the 21st century (pharmaceuticals, medical devices, and regenerative medicine) with people and society to bring about true advantages and happiness for patients, and a multi-trans-inter-disciplinary science that is a new creative science combining the natural sciences and humanities and social sciences. The final objectives of medical RS are to \u201cprovide the latest effective and safe pharmaceuticals, medical devices, and regenerative medicine to patients\u201d and the foundation of all of those objectives is bioethics. In order to build the academic structure for RS, a pluralistic and inter-disciplinary framework for the natural sciences and humanities and social sciences which encompasses many academic fields is essential.
\nWe have founded this institute with the aim of pooling the wisdom of Waseda University in the humanities and sciences in order to promote research into and build an academic structure for medical RS as a science that creates new relationships between cutting-edge medical technologies and people and society in the 21st century.<\/p>\n

Research plan<\/h4>\n

In November 2014 major revisions were made to the Pharmaceutical Affairs Act for the first time in 70 years and it was renamed the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices . Against this background, this institute will conduct research mainly into pharmaceuticals, medical equipment, and regenerative medicine.
\nIn the full life cycle of the fields in the previous paragraph from research and development to examination, manufacturing and sale, this institute will forecast, evaluate, and weigh the risks and benefits based on non-clinical trials, clinical trials and research, aim to achieve an optimal design by reducing the risks and expanding the benefits, and conduct research that leads to a basis for decision-making that depends on scientific rationality and social rationality in the context of uncertainty and asymmetry in medicine and medical care. Moreover, we will conduct ethical, legal and social research in order to build new relationships between rapidly progressing science and technology and humans and society.
\nFurthermore, we will conduct research into evaluation, forecasting, and decision-making regarding costs and benefits in insurance examinations. In order to build systems for health technology assessment and ensure the continuity and consistency of the risks\/benefits\/costs, we will conduct research into the relationship with not only the revised Pharmaceutical Affairs Act but also other laws related to medical matters such as the Insurance Act, Medical Care Act, and Medical Practitioners\u0081f Act, etc.
\nMoreover, we will conduct research into the relationship between innovation and regulation. We will research about the dynamic chain of regulation from the perspective of innovation and risks in terms of benefits and costs. We will conduct research related to the value central to humans of not only human life but also survival, and the change in value from “development-oriented\u0081h to “safety and security-oriented.\u0081h
\nIn parallel with that, we will engage in international harmonization activities with global ecosystems as the key concept, and conduct research into the standardization of approval review standards in the ICH, ISO, etc.
\nIn this institute we will conduct research into the medical technologies supported by society and the citizens, encouragement of the independent participation of the citizens in medical technologies, interactive communication, citizen-participation type technology assessments, consensus conferences, etc.
\nIn addition, we will conduct research into forecasting, evaluation, and decision-making targeting artificial objects (“things\u0081h and \u0081hsystems\u0081h created by humans) with the objective of solving human and social issues arising from artificial objects made with science and technology that is related to health and medical care in the 21st century.
\nIn the process of executing the above projects, we will realize an academic structure for medical regulatory science that enables a meta-paradigm change, and carry out human resources development.<\/p>\n

Adviser<\/h3>\n

Hiroshi Kasanuki<\/p>\n

Researchers<\/h3>\n

Shiro Segawa (Professor, Faculty of Political Science and Economics)
\nHaruko Noguchi (Professor, Faculty of Political Science and Economics)
\nWaichiro Iwashi (Professor, Faculty of Law)
\nKatsunori Kai (Professor, Faculty of Law)
\nHironori Higashide (Professor, Faculty of Commerce)
\nHironori Ayabe (Professor, Faculty of Science and Engineering)
\nAkinori Komatsubara (Professor, Faculty of Science and Engineering)
\nAtsuo Takanishi (Professor, Faculty of Science and Engineering)
\nShinji Takeoka (Professor, Faculty of Science and Engineering)
\nShinichi Suzuki\uff08Professor,Faculty of Human Sciences\uff09
\nHiroshi Iseki (Professor, Faculty of Science and Engineering)
\nKiyotaka Iwasaki (Professor, Faculty of Science and Engineering)
\nMegumu Yokono (Associate professor, Faculty of Social Sciences)
\nTakashi Hasuike (Associate Professor, Faculty of Science and Engineering)
\nYuki Matsuhashi (Research Associate, Faculty of Science and Engineering)
\nHiroyo Karube (Assistant professor, Faculty of Science and Engineering)
\nKtsuhisa Sakaguchi (Researcher, Faculty of Science and Engineering)
\nHiroyuki Ishii (Junior Researcher, Faculty of Science and Engineering)
\nAkira Kawamura (Assistant professor, Faculty of Political Science and Economics)
\nYusuke Tsuboko(Research Associate)
\nTakanobu.Yagi(Researcher, Faculty of Science and Engineering)<\/p>\n

Fumika Aoki(Guest Researcher)<\/p>\n

Adjunct Researcher<\/h3>\n

Shinichi Osaka
\nItsu Sen
\nMasayuki Yamato
\nAtsushi Aruga
\nHitoshi Kasegawa
\nKen Masamune
\nYoshihiro Muragaki
\nMassimiliano Zecca
\nFumika Aoki
\nAkira Onomura
\nYuki Kawase
\nChikako Konoura
\nNaoto Nakamura
\nKazuo Yano
\nAkira Kokubo
\nKazuko Sorimachi
\nWataru Taguchi
\nNobuyuki Hanamura
\nMasahiro Echigo
\nKazuo Iijima
\nTaisuke Ikawa
\nHiroshi Ohtsu
\nTsugiko Kato
\nYukiyoshi Kawamoto
\nMari Kobayashi
\nKazuhiro Sase
\nKenichiro Tsuyuki
\nYoshikazu Nakayama
\nYutaka Hikichi
\nYutaka Matsui
\nKeisuke Matsumoto
\nToru MATSUMOTO
\nMitsuko Mouri
\nToshitaka Yajima
\nFumiaki Ikeno
\nKuniko Shoji
\nNobuyuki Sekine
\nRyota Kitawaki
\nMasayoshi Saito
\nRyoji Otsu
\nYu Amada
\nHiroyo Karube
\nShoji Kuniko
\nYusuke Nomura
\nBan Tomoaki
\nShida Takuya
\nYamawaki Masahiro
\nInoue Tomoko
\nTanaka Yutaka
\nJokura Yoji
\nHaishima Yuji
\nUematsu Miyuki
\nSakota Hideyuki
\nOkamoto Yoshihiro
\nMiyajima Atsuko
\nNakaoka Ryusuke
\nOtake Masanori
\nKamio Tadashi
\nKojima Shigehiro
\nShukuzawa Kota<\/p>\n

Contact<\/h3>\n

Extention:703-3510
\nE-mail:umezu@waseda.jp<\/p>\n

Website<\/h3>\n

https:\/\/www.waseda.jp\/prj-imers\/<\/a>
\n\u25c6UMEZU lab
\nhttp:\/\/www.umezu.mech.waseda.ac.jp\/harp\/index.php<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Director : Mitsuo UMEZU Professor,Faculty of Science and Engineering Research theme Creation of a secure and s […]<\/p>\n","protected":false},"author":1,"featured_media":164,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[],"class_list":["post-326","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-other-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/posts\/326","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/comments?post=326"}],"version-history":[{"count":3,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/posts\/326\/revisions"}],"predecessor-version":[{"id":613,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/posts\/326\/revisions\/613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/media\/164"}],"wp:attachment":[{"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/media?parent=326"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/categories?post=326"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.waseda.jp\/inst\/ori\/wp-json\/wp\/v2\/tags?post=326"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}