Key West, Fl., May 2009 B.I. Choe, M.B.A., LL.M., Ph.D. Associate Professor of Bioethics Nicholas Cardinal Cheong Graduate School for Life Catholic Institute.

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Key West, Fl., May 2009 B.I. Choe, M.B.A., LL.M., Ph.D. Associate Professor of Bioethics Nicholas Cardinal Cheong Graduate School for Life Catholic Institute of Bioethics The Catholic University of Korea

2 Recent Developments in Clinical Trials in Korea – B.I.C.

12 Regional CTCs in Korea 3 Recent Developments in Clinical Trials in Korea – B.I.C.

Two IRBs in Korea  Agent oriented, not Subject oriented IRB for Drug & Medical Device trials IRB for Drug & Medical Device trials IRB for Genetic research IRB for Genetic research  No governing laws or directives for research involving human subjects  Only government certified institutions can and must operate IRB 4 Recent Developments in Clinical Trials in Korea – B.I.C.

Regional Clinical Trial H/R Development Centers  Course development program for Investigator Investigator Clinical Pharmacologist Clinical Pharmacologist Clinical Research Coordinator Clinical Research Coordinator Monitor Monitor PK/PD professionals PK/PD professionals Statistician / Data managers Statistician / Data managers Clinical trial pharmacist Clinical trial pharmacist  Development of integrated online education program for; HRPP HRPP RCR RCR IRB IRB IACUC IACUC Recent Developments in Clinical Trials in Korea – B.I.C. 5

6

Animal Protection Law  Enacted Jan 2008  All institution using animals must be registered  All institution must be reviewed by IACUC  All institution must conduct 8 hours course on animal welfare for both Investigators and Members of IACUC  Mandatory annual report  Lab Animal Law : K-FDA, enacted in 2009 Recent Developments in Clinical Trials in Korea – B.I.C. 7

KAIRB  Korea Association of IRBs An independent foundation of Korean IRBs An independent foundation of Korean IRBs Members : 49 institutions (IRBs) Members : 49 institutions (IRBs) Funded by Ministry of Health, Welfare and Family Affairs Funded by Ministry of Health, Welfare and Family Affairs  Development of Educational Programs Investigators : off-line course Investigators : off-line course IRB reviewers : off-line course IRB reviewers : off-line course CITI-Korea : on-line course CITI-Korea : on-line course 8 Recent Developments in Clinical Trials in Korea – B.I.C.

CITI-Korea and the Authorities  RCR : Ministry of Education Ministry of Education  Human Subject Protection : Ministry of Health Ministry of Health K-FDA K-FDA  Animal Research & IACUC : Ministry of Food, Agriculture, Forestry and Fisheries. Ministry of Food, Agriculture, Forestry and Fisheries. K-APHIS K-APHIS K-FDA K-FDA Recent Developments in Clinical Trials in Korea – B.I.C. 9

Must Show the proof !  Authorities are demanding the proof of education for the proof of education for investigators, investigators, members of review boards members of review boards  But, educational resources are LIMITED ! Everybody is expert Everybody is expert No consolidated programs No consolidated programs No assessment tools No assessment tools Recent Developments in Clinical Trials in Korea – B.I.C. 10

B.I. Choe, M.B.A., LL.M., Ph.D. Director, CITI-Korea The Catholic University of Korea 11 Recent Developments in Clinical Trials in Korea – B.I.C.