1. 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 bichoe@catholic.ac.kr

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

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

4. 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.

5. 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

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7. 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

8. 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.

9. 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

10. 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

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