±³À°¸í | [¸ÓÅ©] Post Approval Changes (PAC) Focused on Biological Products | ºÐ·ù | ¼¼¹Ì³ª |
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½ÅûÀÏÁ¤ | 2024.01.31~2024.02.19 | Çà»çÀÏÁ¤ | 2024.02.20~2024.02.20 |
Àå¼Ò | ¿Â¶óÀÎ | ½Ã°£ | 15:00~16:00 |
[¸ÓÅ©] Post Approval Changes (PAC) Focused on Biological Products
✅ ÁÖÁ¦: Post Approval Changes (PAC) Focused on Biological Products
✅ ÀÏÁ¤: 2024³â 2¿ù 20ÀÏ(È) ¿ÀÈÄ 3½Ã-4½Ã (KST)
¹ÙÀÌ¿ÀÀǾàÇ° Ç°¸ñÇã°¡ ÀÌÈÄ Á¦Á¶¹æ¹ý °³¼±, »ý»ê ±Ô¸ð È®´ë, Ç°Áú Çâ»ó µî ¿©·¯ °¡Áö ¸ñÀûÀ¸·Î Á¦Á¶¹æ¹ýÀÌ º¯°æµÉ ¼ö ÀÖ½À´Ï´Ù. ±Ý¹ø ¿þºñ³ª¿¡¼´Â ¹ÙÀÌ¿ÀÀǾàÇ° Á¦Á¶¹æ¹ý º¯°æ°ü¸®¿¡ ´ëÇÑ ±¹³»¿Ü ±ÔÁ¦¿Í case study¸¦ ¾Ë¾Æº¸°íÀÚ ÇÕ´Ï´Ù.
¿þºñ³ª¿¡¼´Â ´ÙÀ½°ú °°Àº ³»¿ëµéÀ» ´Ù·ç°íÀÚ ÇÕ´Ï´Ù:
l Comparability Exercise with US FDA¡¯s example
l Biologics complexity – focused on cell culture media
l Biologics complexity – focused on downstream process
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