1. The Globalization of Clinical Development Technology - Current Status & NTRM - Sang - Goo Shin, MD. PhD SNU. Coll. Med. February 26, 2003

2. Historical Overview of New Drug Trials  Mid ’80 - New Drug Development in Korea : G7 project etc.  1989-’92 Foreign drug approval – a clinical trial  1992 Oversight of IND-initiated Trials by MHW/KFDA  1992 KGCP Hospitals accreditation – trial sites  1995. 10 KGCP enforcement  1999. 12 ICH-E5 /Changes in Foreign Drug Approval Policy - Bridging concept / Multinational trials  2002. 11 Changes in IND/NDA /Clinical R&D Strategy - on going changes in details/related provisions

3. Number of clinical trials for the new drug approvals Subsidiary Total No official statistics from 1999 ; from ’95 – to ’01. Sept – 166 protocol with registration purpose approved No. of trials

4. Clinical Development of New Drug in Korea as 2002. 8 Approval Postmarketing Progress of Clinical Evaluation PMS Phase IPhase IIa Phase IIbPhase III Spontaneous ADR Monitoring Antimicro Q-35 DW-116 CFC-222 LB-20304A Hepato-Prot YH-439 Antiulcer YH-1885 IL - 009 Anticancer SKI2053R DA-125 CKD AntiHyper SKP-450 Anti-Platelet Asplatone Biologicals CFC-101 DWP-401 Treatment IND GSK Treatment IND GSK Orphan ?

6. Medical department/team in member companies of KPMA, KRPIA & CROs (6) Numbers Joint- Venture or Subsidiary (33) Domestic Companies (216) Medical Profession Independent Medical Dept.

8. CRO ( Contract Research Organization) - As a part of new drug development activity - Roles of CRO are expanding ; monitoring, Database mangement, regulatory affairs, protocol development etc. DreamCIS C & R Research LifeCord Westat-Korea Apex Korea ( Taiwan Apex ) CMIC Korea ( Japan CMIC ) Quintiles Korea

9. Infra-Structure in Major University Hospital Clinical Trial Centers (’95) - 4 Institutions - CTC/SNU : Clin Pharmacol. : Pharmacoepid. Coordination for multicenter trials Major university hospital - seeking efficient systematic flow in patient care setting Institution specific SOPs ?

10. IRB Operation in Korea - 1995. 10 All Accredited KGCP Hospitals l Inconsistency in Protocol Review : Lack of Experiences l KGCPH FDA Accreditation : few Periodical Education l No guiding body for IRB Practices l Other human research review ?  1989 Catholic University Hospital  1992 Asan ChungAng Hospital  1993. 7 Seoul National University Hospital  1994 Yonsei University Hospital 

11. Cooperative Activities Improve GCP Standards - Government / Academy / Industry - Annual Workshop on GCP & IRB ( 1993 -) - Investigators, CRA, IRB members : some Institute  - Clinical Pharmacology Society & Clinical Trial Study Group Workshops on Clinical Trials (1993 - ) - CTC/SNUH and others, Industry-initiated Publication of Clinical Trial Guidelines (’93 – ’98) - by KMHW & expert working group 

27. Future Technology Implementation in Clinical Development

33. NTRM : 임상시험 기술 http;//ntrm.kistep.re.kr/open_page