| 류규하 / Ph.D. |
Name : 류규하 Ph.D.
Department : SAIHST
Title : Professor
Office : SMC Campus Annex B3F
E-mail : gyuha.ryu@samsung.com, gyuharyu@gmail.com
Homepage :
Lab. title :
Related Department : Department of Medical Device Management and Research
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■ Careers 1987 BS, Seoul National University (Microbiology) 1993 PhD, Seoul National University (Biomedical Engineering) 1993 Postdoctoral Research Associate, CCCD, University of Utah, Salt Lake City, UT, USA 1995∼1996 Postdoctoral Research Associate, Department of Molecular & Experimental Medicine, The Scripps Research Institute, La Jolla, CA, USA 1996 –2002 Senior Research Officer, Medical Device Evaluation & Approval Division, Korea Food & Drug Administration 2002–2008 Director, Medical Device Evaluation & Approval Division, Korea Food & Drug Administration 2008–2012 Director General, Medical Device Evaluation & Approval Department, Korea Food & Drug Administration 2013–2014 Invited Professor, Department of Molecular & Cellular Biology, School of Medicine, Sungkyunkwan University Present Professor, Department of Medical Device Management & Research, SAIHST, School of Medicine, Sungkyunkwan University Present Director, A-CRO Team, Research Institute for Future Medicine, Samsung Medical Center ■ Research Summary The mission of our office is to promote the development strategies of R&BD, planning & design, approval, quality management, Clinical trial, Post-market surveillance of medical devices and to create new healthcare service based on digital health & personalized medicine. We are also trying to cultivate global healthcare professionals. Detailed research areas are as follows : (1) Medical products (medical devices, biotechnology, tissue & cell products) and healthcare services related law (2) Approval, quality management, compliance, reimbursement and pricing review of medical products (3) R&BD management of medical products (4) Needs of companies for mergers and acquisitions, new product launches etc. (5) Changes of regulatory requirements in mature and emerging markets (6) Solution to administrative disposition (pre- or post-market control) (7) Solutions to complex legal challenges ■ Keyword Medical device, Biopharmaceuticals, Approval, quality management, Clinical trial, Post-market surveillance, Digital health, Personalized medicine, Healthcare service ■ Selected Publications 1. Prevention effect of orally active heparin conjugate on cancer-associated thrombosis, J Control Release 2014 pii: S0168-3659(14)00330-7. |
