2018 Volume Annual56 Issue Abstract Pages S8
A unique and major challenge to the development of advanced medical devices is adjusting the criteria for determining value among diverse interested parties that may include academia, industrialists, governments as well as patients. Hence, the pressure to harmonize scientific and ethical standards to allow the proper judgements to be made in different circumstances co-exists with the need to establish and develop reliable evaluation techniques. Waseda Institute for Medical Regulatory Science, founded in 2015, approaches these issues from a comprehensive perspective by performing tasks that range from formulating guidelines for advanced medical treatment, based on the foundations of life and medical sciences or medical engineering, to developing professional human resources. In parallel, we jointly established a graduate school for the Cooperative Major in Advanced Biomedical Sciences (Doctoral Program) specializing in medical regulatory science between Waseda University and Tokyo Women's Medical University.