Çѱ¹¹ÙÀÌ¿ÀÀǾàÇ°Çùȸ¿¡¼ ¾È³»µå¸³´Ï´Ù.
ICH¿¡¼´Â Àü¹®°¡À§¿øȸ(Expert Working Group)¿¡¼ ÇÕÀÇµÈ ICH Q12¡¸ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇס¹ °¡À̵å¶óÀÎ(¾È)¿¡ ´ëÇØ °¢±¹ ±ÔÁ¦±â°ü ¹× °ü·Ã ´ÜüÀÇ ÀÇ°ßÀ» ¼ö·ÅÇÏ°í ÀÖ½À´Ï´Ù.
ÀÌ¿¡ ½ÄÇ°ÀǾàÇ°¾ÈÀüÆò°¡¿ø¿¡¼´Â µ¿ °¡À̵å¶óÀÎ(¾È)¿¡ ´ëÇÏ¿© °ü·ÃºÎ¼¿Í ±¹³» Á¦¾à¾÷°è ¹× °ü·Ã´ÜüÀÇ ÀÇ°ßÀ» ¼ö·ÅÇÏ°íÀÚ ÇÏ¿À´Ï, ÀÇ°ßÀÌ ÀÖ´Â °æ¿ì ¡¯18.10.25(¸ñ)±îÁö ºÙÀÓÀÇ °ËÅäÀÇ°ß¼¸¦ ÀÛ¼ºÇÏ¿© ¿ì¸®Çùȸ(johs8739@kobia.kr)·Î Á¦ÃâÇÏ¿© Áֽñ⠹ٶø´Ï´Ù.
[ICH Q12 ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇ×] | |
|
ÁÖ¿ä³»¿ë : 1. °¡À̵å¶óÀÎ • Çã°¡ ÈÄ CMC º¯°æ ½ÅûÀÇ ºÐ·ù(Categorisation of Post-Approval CMC Changes) • °ü¸®Ç׸ñ(Established Conditions, ECs) • Çã°¡ ÈÄ º¯°æ°ü¸® °èȹ(Post-Approval Change Management Protocol, PACMP) • Ç°¸ñ ÀüÁֱ⠰ü¸®(Product Lifecycle Management, PLCM) • ÀǾàÇ° Ç°Áú ½Ã½ºÅÛ ¹× º¯°æ°ü¸®(Pharmaceutical Quality System(PQS) And Change Management) • ±ÔÁ¦´ç±¹ÀÇ Æò°¡¿Í ½ÇÅÂÁ¶»çÀÇ °ü°è(Relationship between Regulatory Assessment and Inspection) • ½ÃÆÇ Ç°¸ñÀÇ Çã°¡ ÈÄ º¯°æ(Post-Approval Changes for Marketed Products)
2. ºÎ·Ï • °ü¸®Ç׸ñ »ç·Ê(ECS-Illustrative Examples) • PACMP »ç·Ê(PACMP-Illustrative Examples) • Ç°¸ñ ÀüÁֱ⠰ü¸®¹®¼ »ç·Ê(Product Lifecycle Management-Illustrative Examples) ¡ØÀÚ¼¼ÇÑ »çÇ×Àº ÷ºÎÆÄÀÏ Âü°í |
°¨»çÇÕ´Ï´Ù.[÷ºÎ]1. Q12 ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇ×(¾È) ¿ø¹®2. Q12 ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇ× ºÎ·Ï(¾È) ¿ø¹®3. Q12 ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇ×(¾È) ±¹¹®¹ø¿ªº»(Âü°í¿ë)4. Q12 ÀǾàÇ° ÀüÁֱ⠰ü¸®¸¦ À§ÇÑ ±â¼ú ¹× ±ÔÁ¦ °í·Á»çÇ× ºÎ·Ï(¾È) ±¹¹®¹ø¿ªº»(Âü°í¿ë) 5. ÀÇ°ß¼ Á¦Ãâ ¾ç½Ä. ³¡