Hiromu Kutsumi
- Director & Professor, Center for Clinical Research and Advanced Medicine
- Regulatory Science
CV
1987 Residency in Medicine, JR Osaka railway Hospital, Osaka, Japan
1989 Fellow in Gastroenterology, JR Osaka railway Hospital, Osaka, Japan
1990 Staff, Department of Gastroenterology, The 2nd Okamoto General Hospital, Uji, Japan
1991 Staff, Department of Gastroenterology, Akashi Municipal Hospital, Akashi, Japan
1996 Assistant Manager, Digestive Disease Center, Kyoto First Red Cross Hospital, Kyoto, Japan
2005 Associate Professor, Department of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Japan
2007 Professor, Division of Community Medicine and Medical Network, Kobe University Graduate School of Medicine, Kobe, Japan
2010 Senior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
2012 Professor, Divison of Innovative Medicine,Department of Gastroenterology, Kobe University Graduate School of Medicine, Kobe, Japan
2015 Director & Professor, Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science
Message
Let's study Regulatory Science.
① How do we minimize clinical trial using non-clinical trial?
② What is public domain in regulation?
Publication
1. M Nagata, N Hoshi, H Yoshinaka, H Shiomi1, M Takenaka, A Masuda, R Uchida, T Azuma, H Kutsumi, “Evaluation of the Xenobiotic Reaction against Hyaluronate-based Bioresorbable Membrane in the Abdominal Cavity” Progress in Biomaterials, First Online: 04 July 2016 DOI: 10.1007/s40204-016-0050-x
2. Yagi Y, Masuda A, Zen Y, Takenaka M, Toyama H, Sofue K, Shiomi H, Kobayashi T, Nakagawa T, Yamanaka K, Hoshi N, Yoshida M, Arisaka Y, Okabe Y, Kutsumi H, Fukumoto T, Ku Y, Azuma T. “Predictive value of low serum pancreatic enzymes in invasive intraductal papillary mucinous neoplasms.” Pancreatology. 2016 pii: S1424-3903(16)31138-3,
3. Masuda A, Shiomi H, Matsuda T, Takenaka M, Arisaka Y, Azuma T, Kutsumi H. “The relationship between pancreatic atrophy after steroid therapy and diabetes mellitus in patients with autoimmune pancreatitis.” Pancreatology. 2014 Sep-Oct;14(5):361-5
4. Kawara F, Inoue J, Takenaka M, Hoshi N, Masuda A, Nishiumi S, Kutsumi H, Azuma T, Ohdaira T. “The influences of pepsin concentrations and pH levels on the disinfective activity of ozone nanobubble water against helicobacter pylori.” Digestion. 2014;90(1):10-7
5. Tamura A, Kutsumi H, “Multiregional medical device development: regulatory perspective.”, Clin. J. Gastroenterology, 7(4), 108–116 (2014).
6. Mori K, Watanabe M, Horiuchi N, Kutsumi H, “The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in postmarketing safety.” Clin. J. Gastroenterology, 7(2), 103–107 (2014).
7. Takenaka M, Fujita T, Sugiyama D, Masuda A, Shimoi H, Sugimoto M, SanukiT,Hayakuma T, Azuma T, Kutsumi H, “What is the most adapted indication of prophylactic pancreatic duct stent within the high-risk group of post-endoscopic retrograde cholangiopancreatography pancreatitis?”, J. Hepatobiliary Pancreat Sci., 21(4), 275-280 (2014).