Sakuma Ichiro
Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:3155-8. doi: 10.1109/EMBC.2013.6610210.
Regulatory science can be defined as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. In addition to engineering researches that create novel medical devices, scientific methods for evaluating efficacy, safety and quality of medical devices are necessary to enable rational and scientific evaluation of the device in device approval process. Engineers and medical doctors involving research and development of novel medical devices are required to have basic knowledge on medical device safety standard, medical device regulation, and relevant methodologies. In Japan, several graduate schools in Japan have started educational programs on regulatory sciences in collaboration of Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2012, program for researches for development of evaluation guidelines for novel medical device products started where personnel exchanges between academic researches institutes and PMDA. Example of these programs will be introduced in the presentation and its impact on improvement of medical device research and development process will be discussed.
监管科学可定义为旨在将科学新产品（如发现的物质、新的科学工具和技术以及知识和信息）以最佳方式引入社会的科学。除了制造新型医疗设备的工程研究外，在医疗器械审批过程中，还需要有评估医疗器械有效性、安全性和质量的科学方法，以便对器械进行合理、科学的评估。参与新型医疗器械研发的工程师和医生需要具备医疗器械安全标准、医疗器械监管及相关方法的基础知识。在日本，日本的几所研究生院已与日本药品和医疗器械管理局（PMDA）合作启动了监管科学教育项目。2012年，启动了新型医疗器械产品评估指南制定研究项目，学术研究机构与PMDA之间进行了人员交流。本报告将介绍这些项目的实例，并讨论其对改进医疗器械研发过程的影响。
