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1. Çà»ç¸í: ¹ÙÀÌ¿À½Ã¹Ð·¯ ½É»ç ±¹Á¦ ¿öÅ©¼ó
2. ÀϽÃ: 2014. 8. 28(¸ñ) 9:30~16:00
3. Àå¼Ò: ½ÄÇ°ÀǾàÇ°¾ÈÀüó ¿À¼Û»ý¸í°úÇдÜÁöÁö¿ø¼¾ÅÍ Áß¾ÓÈÄ»ý°ü ±¹Á¦È¸ÀǽÇ(1Ãþ)
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09:30¡10:00 | REGISTRATION | |
10:00¡10:10 | Opening Remarks | Dr. Yeowon Sohn (Director General, Biopharmaceuticals & Herbal Medicine Evaluation Department, MFDS) |
10:10¡10:50 | Topic 1: The current development status of biosimilar products | Dr. Hyukjae Lee (Celltrion) |
10:50¡11:30 | Topic 2: Review and approval system of biosimilar products in Korea | Dr. Jeewon Joung (MFDS) |
11:30¡13:00 | LUNCH |
|
13:00¡13:40 | Topic 3: Review and approval system of biosimilar products in EU | Dr. Gabriele Reichmann (PEI) |
13:40¡14:10 | Questions & Answers | |
14:10¡14:30 | REFRESHMENT BREAK |
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14:30¡15:00 | Topic 4: Current status of Korea guidelines on the evaluation of biosimilar products | Dr. Kyungtak Nam (MFDS) |
15:00¡15:30 | Topic 5: Current status of EU guidelines on the evaluation of biosimilar products | Dr. Gabriele Reichmann (PEI) |
15:30¡16:00 | Questions & Answers |
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