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

Author:

WATANABE Shinya1,SUGII Narushi2,ISHIKAWA Eiichi1

Affiliation:

1. Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

2. Tsukuba Clinical Research and Development Organization, University of Tsukuba, 2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan

Publisher

AMED iD3 Catalyst Unit

Subject

General Medicine

Reference8 articles.

1. 1. Japan Pharmaceutical Manufacturers Association (JPMA). 2021. Data Book.

2. 2. Froshauer, S. 2017. Careers at biotech start-ups and in entrepreneurship. Cold Spring Harb. Perspect. Biol. 9: a032938.

3. 3. Cabinet Office. 2019. Beyond limits. Unlock our potential—strategies for creation of startup ecosystem to compete with the world top ecosystems—. https://www8.cao.go.jp/cstp/openinnovation/ecosystem/beyondlimits_en.pdf [accessed June 17, 2022].

4. 4. Fukushima, M. 2012. National Translational Research Promotion program opens new era of academic life science R & D. Hokkaido Igaku Zasshi 87: 129–131(in Japanese).

5. 5. Uyama, Y. 2019. The importance of a regulatory science approach for better pharmaceutical regulation. Translat. Regulat. Sci. 1: 8–11.

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