Importance of knowledge and experience in regulatory affairs for promoting pharmaceutical drug and medical device development research: a physician’s point-of-view commentary

抄録

The development of pharmaceutical drugs, medical devices, and bio-centric products has recently progressed by utilizing start-up-style mechanisms and venture investments. As this requires the involvement of various specialists, it is important to have human resource visionaries that can monitor such development and connect everyone involved. Regulatory science knowledge and expertise offer novel development perspectives and are valuable for clinicians who wish to convert translational research into real clinical work. We believe that such knowledge and expertise in regulatory science is indispensable for advancing core translational research, which is the development of pharmaceutical drugs and medical devices. In this way, translation refers to research data and the thinking and planning processes. Working in an academic research organization is undoubtedly far from a physician’s duties. This is challenging but rewarding work, and having different perspectives and knowledge of domains other than clinical expertise can be beneficial.