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CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries

Key West, Fl., May 2009. CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries. 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.

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CITI-Korea “ CITI 硏究倫理 敎育課程 ” : name for Asian countries

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  1. Key West, Fl., May 2009 CITI-Korea“CITI硏究倫理 敎育課程” : name for Asian countries 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. The Korea Recent Developments in Clinical Trials in Korea – B.I.C.

  3. 12 Regional CTCs in Korea 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 Genetic research • No governing laws or directives for research involving human subjects • Only government certified institutions can and must operate IRB Recent Developments in Clinical Trials in Korea – B.I.C.

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

  6. New phase of Animal welfare in Korea Recent Developments in Clinical Trials in Korea – B.I.C.

  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.

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

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

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

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

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