한∙일공동 의약품 연구개발 인력양성 교육프로그램

KDRA-OTSUKA CMC ACADEMY 2011

Chemistry, Manufacturing and Control in Drug Development

(2011. 10. 25(화)-10. 26(수), 서울대학교 호암교수회관 컨벤션센터 2층 무궁화홀)

PROGRAM

10월 25일(화)
12:30~13:00	Registration
13:00~13:20	Opening Remarks	한국신약개발연구조합 보건복지부 한국오츠카제약
13:20~15:20	‣ Once Monthly Injection of Leuprorelin (Formulation Studies and Quality Assurance) - Expecting to learn something new from an old story - ‣ Ｑ＆Ａ	Hajime Toguchi, Ph.D. Otsuka Pharmaceutical Co., Ltd
15:20~15:40	Break
15:40~17:40	‣ Validation of Pharmaceutical Facility and Equipment ‣ Ｑ＆Ａ	Kunio Kawamura, Ph.D. Otsuka Pharmaceutical Co., Ltd
17:40~17:50	Closing
10월 26일(수)
09:30~10:00	Registration
10:00~12:00	‣ Chemistry, manufacturing, and control in the development strategy of biotechnology therapeutics ‣ CMC issues of biotechnology therapeutics ‣ Ｑ＆Ａ	Koji Kawakami, MD, Ph.D Kyoto University
12:00~13:30	Lunch
13:30~15:30	‣ 임상시험에 사용되는 의약품의 품질평가 가이드라인 ‣ Ｑ＆Ａ	식품의약품안전청 의약품심사부 소화계약품과 최선옥 연구관
15:30~15:40	Closing