{"id":4587,"date":"2024-06-17T11:18:31","date_gmt":"2024-06-17T02:18:31","guid":{"rendered":"https:\/\/hansem.com\/?post_type=blog&#038;p=4587"},"modified":"2024-06-18T11:30:33","modified_gmt":"2024-06-18T02:30:33","slug":"%ec%83%9d%eb%aa%85%ea%b3%bc%ed%95%99-%ec%9d%b8%ec%a6%9d%eb%b2%88%ec%97%ad","status":"publish","type":"blog","link":"https:\/\/hansem.com\/ko\/blog\/%ec%83%9d%eb%aa%85%ea%b3%bc%ed%95%99-%ec%9d%b8%ec%a6%9d%eb%b2%88%ec%97%ad\/","title":{"rendered":"\uc0dd\uba85 \uacfc\ud559 \ubc0f \uc784\uc0c1 \uc2dc\ud5d8\uc744 \uc704\ud55c \uc778\uc99d \ubc88\uc5ed\uc758 \uc911\uc694\uc131"},"content":{"rendered":"\n<p>\uc784\uc0c1 \uc2dc\ud5d8\uc744 &#8220;\uc801\ub2f9\ud55c \uc218\uc900&#8221;\uc758 \ubc88\uc5ed\uc73c\ub85c FDA \uc2b9\uc778 \uc808\ucc28\ub97c \ub2e8\ucd95\ud558\ub824\uace0 \ud558\uba74 \uc2dc\uc7a5 \uc9c4\uc785 \uc804\ub7b5\uc5d0 \ud070 \ucc28\uc9c8\uc774 \uc0dd\uae38 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc2e4\uc81c\ub85c FDA\ub294 \ubc88\uc5ed \uc815\ud655\uc131\uc744 \ubcf4\uc99d\ud558\ub294 \uc778\uc99d\uc11c\uac00 \uc5c6\ub294 \uc81c\ucd9c \ubb38\uc11c\ub97c \uac70\ubd80\ud558\ub294 \uac83\uc73c\ub85c \uc54c\ub824\uc838 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc0c1\ud669\uc740 \ube44\uc988\ub2c8\uc2a4\uc5d0 \uc0c1\ub2f9\ud55c \ub3c4\uc804 \uacfc\uc81c\ub97c \uc81c\uc2dc\ud560 \ubfd0\ub9cc \uc544\ub2c8\ub77c \uacf5\uc911 \ubcf4\uac74 \uce21\uba74\uc5d0\uc11c\ub3c4 \uc2ec\uac01\ud55c \uc601\ud5a5\uc744 \ubbf8\uce69\ub2c8\ub2e4. \uc0ac\ub78c\ub4e4\uc758 \uc0dd\uba85\uc774 \uadc0\uc0ac\uc758 \uc784\uc0c1 \uc2dc\ud5d8 \uacb0\uacfc\uc5d0 \ub2ec\ub824 \uc788\uc744 \ub54c, \ud558\ub8e8\uc758 \uc9c0\uc5f0\uc740 \ub354 \ub9ce\uc740 \ud658\uc790\ub4e4\uc774 \ud544\uc218\uc801\uc778 \uc758\ub8cc \uc11c\ube44\uc2a4\ub97c \ubc1b\uc9c0 \ubabb\ud558\ub294 \uac83\uc744 \uc758\ubbf8\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub530\ub77c\uc11c \uc0dd\uba85 \uacfc\ud559 \ubc88\uc5ed \uc11c\ube44\uc2a4\ub294 \uc5c4\uaca9\ud55c \uae30\uc900\uc744 \ub530\ub77c\uc57c \ud569\ub2c8\ub2e4. \uc5b8\uc5b4 \uac80\uc99d, \uc778\uc99d \ubc0f \uc804\ubb38\uac00 \uc9c0\uc2dd\uc740 \uc784\uc0c1 \uc2dc\ud5d8\uc744 \uc2dc\uc791\ud558\uace0 \uc644\ub8cc\ud558\uba70 \uacf5\uc911 \ubcf4\uac74\uc744 \ubcf4\ud638\ud558\uace0 \uacfc\ud559\uc801 \ubb34\uacb0\uc131\uc744 \uc720\uc9c0\ud558\ub294 \ub370 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc778\uc99d \ubc88\uc5ed\uc740 \uc774\ub7ec\ud55c \uae30\uc900\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574 \ud544\uc694\ud55c \uc815\ud655\uc131\uacfc \uae30\uc220\uc801 \uc804\ubb38\uc131\uc744 \uc81c\uacf5\ud558\ubbc0\ub85c \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uc778\uc99d-\ubc88\uc5ed\uc774\ub780-\ubb34\uc5c7\uc778\uac00\">\uc778\uc99d \ubc88\uc5ed\uc774\ub780 \ubb34\uc5c7\uc778\uac00?<\/h3>\n\n\n\n<p>\uc778\uc99d \ubc88\uc5ed\uc740 \ub2e4\uc74c \ub450 \uac00\uc9c0 \ud544\uc218 \uc870\uac74\uc744 \ub3d9\uc2dc\uc5d0 \ucda9\uc871\ud558\ub294 \ubb38\uc11c\uc785\ub2c8\ub2e4:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-green-cyan-color\">\uc790\uaca9\uc744 \uac16\ucd98 \ubc88\uc5ed\uac00\uac00 \uc6d0\ubcf8 \ubb38\uc11c\uc758 \ubaa8\ub4e0 \ub0b4\uc6a9\uc744 \uc815\ud655\ud558\uac8c \ubc88\uc5ed\ud569\ub2c8\ub2e4.<\/mark><\/li>\n\n\n\n<li><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-vivid-green-cyan-color\">\ubc88\uc5ed\uc758 \uc815\ud655\uc131\uacfc \uc644\uc804\uc131\uc744 \ud655\uc778\ud558\ub294 \uc778\uc99d\uc11c\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/mark><\/li>\n<\/ol>\n\n\n\n<p>\uc0dd\uba85 \uacfc\ud559 \uc0b0\uc5c5\uc5d0\uc11c \uc778\uc99d \ubc88\uc5ed\uc774 \ud544\uc694\ud55c \ubb38\uc11c\uc5d0\ub294 \ub2e4\uc74c\uacfc \uac19\uc740 \uac83\uc774 \ud574\ub2f9\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\uc784\uc0c1\uc2dc\ud5d8<\/strong>: \uc758\ub8cc \ubb38\uc11c, \ub3d9\uc758\uc11c, \uc784\uc0c1\uc2dc\ud5d8 \uacc4\uc57d\uc11c \ubc0f \uc784\uc0c1 \uc5f0\uad6c \ud504\ub85c\ud1a0\ucf5c (\ucc38\uac00\uc790 \uc774\ud574 \ubc0f \uad6d\uc81c \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574)<\/li>\n\n\n\n<li><strong>\uc758\ub8cc \uae30\uae30<\/strong>: \uc0ac\uc6a9\uc124\uba85\uc11c, \uc548\uc804 \ub370\uc774\ud130 \uc2dc\ud2b8 \ubc0f \uaddc\uc81c \uc81c\ucd9c\uc11c (\ub2e4\uc591\ud55c \uaddc\uc81c \uae30\uad00\uc758 \uae30\uc900\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574)<\/li>\n\n\n\n<li><strong>\uc758\uc57d\ud488<\/strong>: \uc57d\ubb3c \ud3ec\uc7a5, \ud658\uc790 \uc815\ubcf4 \uc804\ub2e8\uc9c0 \ubc0f \ub9c8\ucf00\ud305 \uc790\ub8cc (\ubcf5\uc6a9 \uc9c0\uce68, \ubd80\uc791\uc6a9 \ubc0f \ub9c8\ucf00\ud305 \uba54\uc2dc\uc9c0\ub97c \uc815\ud655\ud558\uac8c \uc804\ub2ec\ud558\uae30 \uc704\ud574)<\/li>\n\n\n\n<li><strong>\uc5f0\uad6c \ubc0f \ucd9c\ud310\ubb3c<\/strong>: \uc5f0\uad6c \ub17c\ubb38 \ubc0f \uacfc\ud559 \ucd9c\ud310\ubb3c (\uacb0\uacfc\ub97c \uc815\ud655\ud558\uac8c \ud45c\ud604\ud558\uace0 \uad6d\uc81c \uae30\uad00\ub4e4\uc774 \uac80\ud1a0\ud560 \uc218 \uc788\ub3c4\ub85d \ud558\uae30 \uc704\ud574)<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\ubc88\uc5ed\uac00-\uc778\uc99d-\ud488\uc9c8-\uc778\uc99d-\ubc0f-\uc778\uc99d-\ubc88\uc5ed\uc758-\ucc28\uc774\uc810\">\ubc88\uc5ed\uac00 \uc778\uc99d, \ud488\uc9c8 \uc778\uc99d \ubc0f \uc778\uc99d \ubc88\uc5ed\uc758 \ucc28\uc774\uc810<\/h3>\n\n\n\n<p>\uac01\uac01\uc740 \ubcc4\uac1c\uc758 \uae30\ub2a5\uc744 \uc218\ud589\ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubc88\uc5ed\uac00\uc758 \uc804\ubb38\uc131\uc744 \uac80\uc99d\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubc88\uc5ed \ud504\ub85c\uc138\uc2a4\uc758 \uc801\ud569\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ub2e8\uc77c \ubc88\uc5ed \ubb38\uc11c\uc758 \uc815\ud655\uc131\uc744 \uba85\uc2dc\uc801\uc73c\ub85c \uc99d\uba85\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\uc790\uc138\ud788 \uc0b4\ud3b4\ubcf4\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\ubc88\uc5ed\uac00 \uc778\uc99d<\/strong>\uc740 \uac1c\ubcc4 \ubc88\uc5ed\uac00\uc758 \ub2a5\ub825\uc744 \uac80\uc99d\ud569\ub2c8\ub2e4. \uc774\ub294 \uc885\uc885 <a href=\"https:\/\/www.atanet.org\/\">\ubbf8\uad6d \ubc88\uc5ed\uac00 \ud611\ud68c(ATA)<\/a>\uc640 \uac19\uc740 \uc804\ubb38 \uc870\uc9c1\uc5d0\uc11c \ubc1c\uae09\ud558\uba70, \ubc88\uc5ed\uac00\uac00 \ud2b9\uc815 \uc804\ubb38 \ub2a5\ub825 \uae30\uc900\uc744 \ucda9\uc871\ud588\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p><strong>\ud488\uc9c8 \uc778\uc99d<\/strong>\uc740 \ubc88\uc5ed \uc11c\ube44\uc2a4 \uc81c\uacf5\uc790\uac00 \ucd5c\uc0c1\uc758 \uad00\ud589\uc744 \ub530\ub974\uace0 \ubc88\uc5ed \ud504\ub85c\uc138\uc2a4 \uc804\ubc18\uc5d0 \uac78\uccd0 \ub192\uc740 \ud488\uc9c8\uc744 \uc720\uc9c0\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uc774\ub294 \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed \uc11c\ube44\uc2a4\uc5d0 \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iso.org\/standard\/59149.html\">ISO 17100<\/a>\uc740 \ubc88\uc5ed \uc11c\ube44\uc2a4\uc758 \ud488\uc9c8\uacfc \uc804\ub2ec\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce60 \uc218 \uc788\ub294 \uc694\uad6c \uc0ac\ud56d\uc744 \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/62085.html\">ISO 9001<\/a>\uc740 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc758 \uae30\uc900\uc744 \uc124\uc815\ud558\uba70, \uace0\uac1d \uc911\uc2ec, \ucd5c\uace0 \uacbd\uc601\uc9c4\uc758 \ucc38\uc5ec, \ud504\ub85c\uc138\uc2a4 \uc811\uadfc \ubc29\uc2dd \ubc0f \uc9c0\uc18d\uc801\uc778 \uac1c\uc120\uc744 \ud3ec\ud568\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a>\ub294 \uc870\uc9c1\uc774 \uace0\uac1d \ubc0f \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud558\ub294 \uc758\ub8cc \uae30\uae30 \ubc0f \uad00\ub828 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud560 \uc218 \uc788\ub294 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc758 \uc694\uad6c \uc0ac\ud56d\uc744 \uba85\uc2dc\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uc784\uc0c1-\uc5f0\uad6c-\uae30\uad00-cro-\uc744-\uc704\ud55c-\uc778\uc99d-\ubc88\uc5ed\uc758-\uc911\uc694\uc131\">\uc784\uc0c1 \uc5f0\uad6c \uae30\uad00(CRO)\uc744 \uc704\ud55c \uc778\uc99d \ubc88\uc5ed\uc758 \uc911\uc694\uc131<\/h3>\n\n\n\n<p>\uc778\uc99d\ub41c \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed\uc740 \uc815\ud655\uc131\uacfc \uaddc\uc815\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \ubbf8\uad6d\uc5d0\uc11c\ub294 <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=10.20#:~:t\">FDA<\/a>\uac00 \uc678\uad6d\uc5b4 \ubc88\uc5ed\ubb3c\uacfc \ud568\uaed8 \ubc88\uc5ed \ucd9c\ucc98\ub97c \ud3ec\ud568\ud558\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4. \uc774 \ubc88\uc5ed\uc5d0\ub294 \ubc88\uc5ed\uac00\uc758 \uc774\ub984, \uc8fc\uc18c \ubc0f \uc790\uaca9 \uc694\uac74\uc744 \uac04\ub7b5\ud788 \uc124\uba85\ud558\ub294 \ubb38\uad6c\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ub610\ud55c, \ubb38\ud5cc \ub610\ub294 \uae30\ud0c0 \uc790\ub8cc\uc758 \ubc88\uc5ed\uc5d0\ub294 \uc6d0\ubcf8 \ucd9c\ud310\ubb3c\uc758 \uc0ac\ubcf8\uc774 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uaddc\uce59\uc5d0\ub294 \uc608\uc678\uac00 \uc5c6\uc2b5\ub2c8\ub2e4. \uc6b0\ub9ac\ub294 \ucd5c\uadfc \uc778\uc99d\ub418\uc9c0 \uc54a\uc740 \ubc88\uc5ed\uc73c\ub85c \uc778\ud574 \uc0c1\ub2f9\ud55c \uc9c0\uc5f0\uacfc \ube44\uc6a9\uc774 \ubc1c\uc0dd\ud55c \uc81c\uc57d \ud68c\uc0ac\ub97c \uc9c0\uc6d0\ud588\uc2b5\ub2c8\ub2e4. \uc778\uc99d\uc11c\uac00 \ucca8\ubd80\ub418\uc9c0 \uc54a\uc544\uc11c FDA\uc5d0\uc11c \ubb38\uc11c\uac00 \uac70\ubd80\ub2f9\ud55c \uc774 \ud68c\uc0ac\ub294 \uae34\uae09\ud788 100\ud398\uc774\uc9c0\uc758 \uc601\uc5b4-\uc911\uad6d\uc5b4 \ubb38\uc11c\ub97c \uc7ac\uac80\ud1a0\ud558\uace0 \uc815\ud655\uc131 \uc778\uc99d\uc11c\ub97c \uc81c\uacf5\ud558\uae30 \uc704\ud574 \ud55c\uc0d8\uae00\ub85c\ubc8c\uc744 \ucc3e\uc558\uc2b5\ub2c8\ub2e4. \uace0\uac1d\uc0ac\ub294 \uc774 \uacfc\uc815\uc5d0\uc11c \uc218\uc2ed\ub9cc \ub2ec\ub7ec\uc758 \ube44\uc6a9\uacfc \uc9c0\uc5f0\uc73c\ub85c \uc778\ud55c \uc7a0\uc7ac\uc801 \uc190\uc2e4\uc774 \ubc1c\uc0dd\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc720\uc0ac\ud55c \uaddc\uc81c\uac00 \uc874\uc7ac\ud558\uba70, \uc774\ub294 \uc758\ub8cc \uae30\uae30 \ubc0f \uc758\uc57d\ud488 \uc2b9\uc778 \uacfc\uc815\uc758 \ubcf5\uc7a1\uc131\uc744 \ubc18\uc601\ud569\ub2c8\ub2e4. \uc784\uc0c1 \uc2dc\ud5d8\uc5d0 \ucc38\uc5ec\ud558\ub294 \uc784\uc0c1 \uc5f0\uad6c \uae30\uad00(CRO) \ubc0f \uae30\ud0c0 \uae30\uad00\uc740 \uc774\ub7ec\ud55c \uaddc\uc815\uc744 \uc900\uc218\ud558\uae30 \uc704\ud574 \ubc88\uc5ed\uc758 \uc815\ud655\uc131\uc744 \ubcf4\uc7a5\ud574\uc57c \ud569\ub2c8\ub2e4. \ub9ce\uc740 \uad6d\uac00\uc5d0\uc11c\ub294 \uc778\uc99d\ub41c \uc804\ubb38\uac00\ub9cc\uc774 \uc2b9\uc778 \uc81c\ucd9c \ubb38\uc11c\ub97c \ubc88\uc5ed\ud560 \uc218 \uc788\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4. \uc77c\ubd80 \uc9c0\uc5ed \ub2f9\uad6d\uc740 \ud2b9\uc815 \ud615\uc2dd, \uacf5\uc99d\ub41c \uc9c4\uc220\uc11c \ub610\ub294 \ucd94\uac00 \uc778\uc99d\uc744 \uc694\uad6c\ud560 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uc808\ucc28\ub97c \uc18c\ud640\ud788 \ud558\uba74 \uaddc\uc81c \uc9c0\uc5f0, \uc7ac\uc815\uc801 \uc190\uc2e4 \ubc0f \uc0b0\uc5c5 \ub0b4 \ud3c9\ud310 \uc190\uc0c1\uc774 \ucd08\ub798\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uc778\uc99d-\ubc88\uc5ed\uc744-\ubc1b\ub294-\ubc29\ubc95\">\uc778\uc99d \ubc88\uc5ed\uc744 \ubc1b\ub294 \ubc29\ubc95<\/h3>\n\n\n\n<p>\ucd08\uae30 \ud3c9\uac00, \ubc88\uc5ed\uac00 \uc120\ud0dd, \ubc88\uc5ed, \uac80\ud1a0, \ud488\uc9c8 \uad00\ub9ac \ubc0f \uc778\uc99d \uacfc\uc815\uc744 \uc774\ud574\ud558\uba74 \ud0c0\uc784\ub77c\uc778\uc744 \uc608\uc0c1\ud558\uace0 \uae30\ub300\uce58\ub97c \uad00\ub9ac\ud558\uba70 \uc7a0\uc7ac\uc801 \ubb38\uc81c\ub97c \ud6a8\uacfc\uc801\uc73c\ub85c \ud574\uacb0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub2e4\uc74c\uc740 \uacfc\uc815\uc5d0 \ub300\ud55c \uc790\uc138\ud55c \uc124\uba85\uc785\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\ucd08\uae30 \ud3c9\uac00<\/strong>: \ud504\ub85c\uc81d\ud2b8 \uad00\ub9ac\uc790 \ubc0f \ud300\uc774 \ubb38\uc11c\ub97c \ud3c9\uac00\ud558\uc5ec \ubcf5\uc7a1\uc131\uacfc \ud2b9\uc815 \uc694\uad6c \uc0ac\ud56d\uc744 \uc774\ud574\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ubc88\uc5ed\uac00 \uc120\ud0dd<\/strong>: \ud504\ub85c\uc81d\ud2b8 \uad00\ub9ac\uc790\ub294 \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed \uc11c\ube44\uc2a4\uc5d0 \ub300\ud55c \uc804\ubb38 \uc9c0\uc2dd\uc744 \uac16\ucd98 \uc790\uaca9 \uc788\ub294 \uc778\uc99d \ubc88\uc5ed\uac00\ub97c \ubc30\uc815\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\ubc88\uc5ed:<\/strong> \uc804\ubb38\uac00\ub294 \uc6d0\ubcf8 \ub0b4\uc6a9\uc744 \uc815\ud655\ud558\uac8c \ub300\uc0c1 \uc5b8\uc5b4\ub85c \ubc88\uc5ed\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uac80\ud1a0 \ubc0f \ud488\uc9c8 \uad00\ub9ac:<\/strong> \ubc88\uc5ed\ub41c \ubb38\uc11c\ub294 \uc5ec\ub7ec \ucc28\ub840 \uac80\ud1a0 \ubc0f \ud488\uc9c8 \uad00\ub9ac \ub2e8\uacc4\ub97c \uac70\uce69\ub2c8\ub2e4. \uc774 \uacfc\uc815\uc5d0\ub294 \ub450 \ubc88\uc9f8 \ubc88\uc5ed\uac00 \ub610\ub294 \uc8fc\uc81c \uc804\ubb38\uac00\uac00 \ucc38\uc5ec\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc778\uc99d:<\/strong> \ubc88\uc5ed\uc774 \uac80\uc99d\ub418\uba74 \ubc88\uc5ed\uac00\ub294 \uc815\ud655\uc131\uacfc \uc644\uc804\uc131\uc744 \uc99d\uba85\ud558\ub294 \uc11c\uba85\ub41c \uc778\uc99d\uc11c\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li><strong>\uc804\ub2ec \ubc0f \ucd5c\uc885 \uac80\ud1a0<\/strong>: \uc778\uc99d \ubc88\uc5ed \ubc0f \uc815\ud655\uc131 \uc778\uc99d\uc11c\ub97c \ubc1b\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p>\uc774\uc81c \ud544\uc694\ud55c \ub2e8\uacc4\ub97c \uc774\ud574\ud588\uc73c\ubbc0\ub85c \uc0dd\uba85\uacfc\ud559 \ubc88\uc5ed \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud560 \uc218 \uc788\ub294 \uc801\uc808\ud55c \uc804\ubb38\uac00\ub97c \ucc3e\ub294 \ubc29\ubc95\uc744 \uc54c\uc544\ubcf4\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-\uacbd\ud5d8-\ub9ce\uc740-\uc5b8\uc5b4-\uc11c\ube44\uc2a4-\ud68c\uc0ac-\uc120\ud0dd\">\uacbd\ud5d8 \ub9ce\uc740 \uc5b8\uc5b4 \uc11c\ube44\uc2a4 \ud68c\uc0ac \uc120\ud0dd<\/h4>\n\n\n\n<p>\uc5b8\uc5b4 \uc11c\ube44\uc2a4 \ud68c\uc0ac (Language Service Provider, \uc774\ud558 LSP. \ubc88\uc5ed \ud604\uc9c0\ud654 \uc5c5\uacc4\uc5d0\uc11c \uc0ac\uc6a9\ub418\ub294 \ud45c\uc900 \uc6a9\uc5b4)\ub294 \uc81c\uc57d, \uc0dd\uba85\uacf5\ud559, \uc758\ub8cc \uae30\uae30 \ubc0f \uc784\uc0c1 \uc5f0\uad6c \uae30\uad00(CRO) \ub4f1 \uc0dd\uba85\uacfc\ud559 \uc0b0\uc5c5\uc5d0 \ub300\ud55c \uae4a\uc740 \uc9c0\uc2dd\uc744 \ubcf4\uc720\ud574\uc57c \ud569\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c\ub97c \ub2e4\ub8e8\ub294 \uc804\ubb38\uac00\ub4e4\uc774 \ubcf5\uc7a1\ud55c \uc6a9\uc5b4\uc640 \ud2b9\uc815 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc744 \uc774\ud574\ud558\uace0 \uc788\ub294\uc9c0 \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ucd5c\uc0c1\uc758 \uacb0\uacfc\ub97c \uc5bb\uc73c\ub824\uba74 \uc784\uc0c1\uc2dc\ud5d8 \ud504\ub85c\ud1a0\ucf5c, \uaddc\uc81c \uc81c\ucd9c\uc11c \ubc0f \ud658\uc790 \uc815\ubcf4 \uc804\ub2e8\uc9c0\ub97c \ubc88\uc5ed\ud55c \uacbd\ud5d8\uc774 \uc788\ub294 \uc5c5\uccb4\ub97c \ucc3e\uc73c\uc2ed\uc2dc\uc624. \uc0ac\ub840 \uc5f0\uad6c \ub610\ub294 \uace0\uac1d \ucd94\ucc9c\uc11c\ub294 \uadf8\ub4e4\uc758 \uc131\uacfc\uc5d0 \ub300\ud55c \ud1b5\ucc30\ub825\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub2e4\uc74c\uc740 \uba87 \uac00\uc9c0 \uc804\ubb38\uac00 \ud301\uc785\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>LSP\ub294 \ud658\uc790 \ubcf4\uace0 \uacb0\uacfc(PRO) \ubc0f \uc784\uc0c1 \uacb0\uacfc \ud3c9\uac00(COA)\uc5d0 \ub300\ud55c \uc5b8\uc5b4 \uac80\uc99d \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubbf8\uad6d FDA, <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\">EU EMA<\/a> \ubc0f \uae30\ud0c0 \uc9c0\uc5ed \ub2f9\uad6d\uc744 \ud3ec\ud568\ud55c \ub2e4\uc591\ud55c \uad6d\uac00\uc758 \uaddc\uc81c \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub300\ud55c \uacbd\ud5d8\uc774 \uc788\ub294 LSP\uc640 \ud611\ub825\ud558\uc2ed\uc2dc\uc624.<\/li>\n\n\n\n<li>\uadf8\ub4e4\uc758 \ud504\ub85c\uc138\uc2a4 \ubc0f \ub3c4\uad6c\uc5d0 \ub300\ud574 \ubb38\uc758\ud558\uc2ed\uc2dc\uc624. \uc62c\ubc14\ub974\uac8c \uc0ac\uc6a9\ub420 \uacbd\uc6b0, \uace0\uae09 \ubc88\uc5ed \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc740 \ubc88\uc5ed \ud488\uc9c8\uacfc \ud6a8\uc728\uc131\uc744 \ud5a5\uc0c1\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc8fc\uc81c \uc804\ubb38\uac00\uc5d0 \uc758\ud55c \ub2e4\uc911 \uac80\ud1a0 \ubc0f \ud3b8\uc9d1\uc744 \ud3ec\ud568\ud55c \ud3ec\uad04\uc801\uc778 \ud488\uc9c8 \ubcf4\uc99d\uc744 \uc694\uccad\ud558\uc2ed\uc2dc\uc624.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"h-\ubc88\uc5ed\uc758-\ubc94\uc704\uc640-\ubaa9\uc801-\uba85\ud655\ud788-\ud558\uae30\">\ubc88\uc5ed\uc758 \ubc94\uc704\uc640 \ubaa9\uc801 \uba85\ud655\ud788 \ud558\uae30<\/h4>\n\n\n\n<p>\ubaa9\ud45c \uc5b8\uc5b4\uc5d0 \uc9c0\uc5ed\uc801 \ubcc0\ud615\uc774 \uc788\ub294 \uacbd\uc6b0(\uc608: \ube0c\ub77c\uc9c8 \ud3ec\ub974\ud22c\uac08\uc5b4 vs. \uc720\ub7fd \ud3ec\ub974\ud22c\uac08\uc5b4), \uc815\ud655\ud55c \uc5b8\uc5b4\ub97c \uc9c0\uc815\ud558\uc5ec \ubc88\uc5ed\uc774 \ubb38\ud654\uc801\uc73c\ub85c \uc801\uc808\ud558\ub3c4\ub85d \ud558\uc2ed\uc2dc\uc624. \ub610 \ub2e4\ub978 \uc911\uc694\ud55c \uc138\ubd80 \uc0ac\ud56d\uc740 \ubb38\uc11c\uc758 \ubaa9\uc801\uc785\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \ubc88\uc5ed\uac00\ub294 \uc5b8\uc5b4\ub97c \uc801\uc808\ud788 \uc870\uc815\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4, \uc2dc\ud5d8 \ucc38\uac00\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud558\ub294 \ud658\uc790 \uc815\ubcf4 \uc804\ub2e8\uc740 \ub354 \uac04\ub2e8\ud558\uace0 \uc811\uadfc \uac00\ub2a5\ud55c \uc5b8\uc5b4\ub97c \uc0ac\uc6a9\ud558\uace0, \uaddc\uc81c \uc81c\ucd9c \uc11c\ub958\ub294 \ud45c\uc900\uc744 \ucda9\uc871\ud558\uae30 \uc704\ud574 \uc815\ud655\ud55c \ubc95\uc801 \ubc0f \uacfc\ud559\uc801 \uc6a9\uc5b4\ub97c \ud544\uc694\ub85c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ub610\ud55c, \ub2e4\uc74c\uc744 \uc81c\uacf5\ud574\uc57c \ud569\ub2c8\ub2e4:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc6a9\uc5b4\uc9d1, \uc774\uc804 \ubc88\uc5ed, \ud2b9\uc815 \uc6a9\uc5b4 \ub370\uc774\ud130\ubca0\uc774\uc2a4 \ubc0f \uc2a4\ud0c0\uc77c \uac00\uc774\ub4dc \ub4f1 \ubaa8\ub4e0 \ud544\uc694\ud55c \ucc38\uace0 \uc790\ub8cc\ub97c LSP\uc5d0 \uc81c\uacf5\ud558\uc2ed\uc2dc\uc624.<\/li>\n\n\n\n<li>\ubb38\uc11c\uc5d0 \ub300\ud55c \uc0c1\uc138\ud55c \ub9e5\ub77d \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uc2ed\uc2dc\uc624. \uc5ec\uae30\uc5d0\ub294 \uc784\uc0c1 \uc2dc\ud5d8\uc758 \ubc30\uacbd, \uc900\uc218\ud574\uc57c \ud558\ub294 \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c \ubc0f \uace0\ub824\ud574\uc57c \ud560 \ud2b9\uc815 \uc9c0\uce68\uc774\ub098 \ub258\uc559\uc2a4\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubc88\uc5ed \uc911\uc5d0 \uba85\ud655\ud55c \uc758\uc0ac\uc18c\ud1b5 \ub77c\uc778\uc744 \uad6c\ucd95\ud558\uc2ed\uc2dc\uc624. \uc815\uae30\uc801\uc778 \uc5c5\ub370\uc774\ud2b8\uc640 \ud53c\ub4dc\ubc31 \ub8e8\ud504\ub294 \ubc88\uc5ed\uc744 \uada4\ub3c4\uc5d0 \uc62c\ub9ac\uace0 \uc900\uc218\uc640 \uc815\ud655\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uae30\ud0c0-\uc8fc\uc694-\uace0\ub824\uc0ac\ud56d-ai\uc640-\ube44\uc6a9\">\uae30\ud0c0 \uc8fc\uc694 \uace0\ub824\uc0ac\ud56d: AI\uc640 \ube44\uc6a9<\/h3>\n\n\n\n<p>\ub610\ud55c \uace0\ub824\ud574\uc57c \ud560 \ub450 \uac00\uc9c0 \uc0ac\ud56d\uc740 AI\uc758 \uc0ac\uc6a9\uacfc \ube44\uc6a9 \uc694\uc18c\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>AI \uc0ac\uc6a9\uc740 \uad8c\uc7a5\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ucd5c\uc2e0 AI \uae30\uc220\uc870\ucc28\ub3c4 \uc0dd\uba85\uacfc\ud559\uacfc \uad00\ub828\ub41c \ubcf5\uc7a1\ud55c \uc0ac\ud56d\uacfc \uad00\ub8cc\uc801 \ub258\uc559\uc2a4\ub97c \ubd80\ubd84\uc801\uc73c\ub85c\ub9cc \uc774\ud574\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uac01 \ub2e8\uacc4\uc5d0\uc11c \uc778\uac04 \uc804\ubb38 \ubc88\uc5ed\uac00\uc5d0 \uc758\ud574\uc11c \uc774\ub8e8\uc5b4\uc9c4 \ubc88\uc5ed\ub9cc\uc774, \ud544\uc694\ud55c \uaddc\uc81c \ubc0f \ub9e5\ub77d\uc801 \uc694\uad6c \uc0ac\ud56d\uc744 \uc900\uc218\ud558\ub3c4\ub85d \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uad11\ubc94\uc704\ud55c \uac80\ud1a0 \ubc0f \uc778\uc99d \uc808\ucc28\ub85c \uc778\ud574 \uc778\uc99d\ub41c \ubc88\uc5ed\uc740 \ube44\uc6a9\uc774 \ub354 \ub9ce\uc774 \ub4e4\uace0 \uc644\ub8cc\ud558\ub294 \ub370 \ub354 \uc624\ub79c \uc2dc\uac04\uc774 \uac78\ub9bd\ub2c8\ub2e4. \uc2e0\uc18d\ud55c \uc11c\ube44\uc2a4\uc5d0\ub294 \ucd94\uac00 \ube44\uc6a9\uc774 \ubc1c\uc0dd\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-\uacb0\ub860\">\uacb0\ub860<\/h3>\n\n\n\n<p>\ub9de\uc2b5\ub2c8\ub2e4, \uace0\ud488\uc9c8 \uc778\uc99d \ubc88\uc5ed\uc740 \uaddc\uc81c \ud544\uc694\uc131\uc785\ub2c8\ub2e4. \uadf8\ub7ec\ub098 \uc774\uac83\uc740 \ub610\ud55c \uc784\uc0c1 \uc2dc\ud5d8\uacfc \uc758\uc57d \uc81c\ud488\uc758 \ubb34\uacb0\uc131\uacfc \uc131\uacf5\uc744 \uc9c0\uc6d0\ud558\ub294 \uc804\ub7b5\uc801 \uc774\uc810\uc774\uae30\ub3c4 \ud569\ub2c8\ub2e4. \uc778\uc99d\ub41c \uc0dd\uba85 \uacfc\ud559 \ubc88\uc5ed\uc744 \ud1b5\ud574 \uc784\uc0c1 \uc2dc\ud5d8 \ubb38\uc11c\uac00 \ubaa8\ub4e0 \uc0b0\uc5c5 \ud45c\uc900\uc744 \ucda9\uc871\ud55c\ub2e4\ub294 \ud655\uc2e0\uc744 \uac00\uc9c8 \uc218 \uc788\uc73c\uba70, \ubaa9\ud45c \ub2ec\uc131, \ub9c8\uac10 \uc900\uc218 \ubc0f \uc2dc\uc7a5 \uc9c4\ucd9c \uc77c\uc815 \uc900\uc218\ub97c \ub3c4\uc6b8 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uace0\uac1d\uc0ac\uc758 \uc804\ubb38 \ubd84\uc57c\uc5d0 \ub300\ud55c \uc774\ud574\uc640 \ubaa9\ud45c \uc2dc\uc7a5 \ub2f9\uad6d\uc758 \ud2b9\uc815 \uc694\uad6c \uc0ac\ud56d\uc744 \ucda9\uc871\ud560 \uc218 \uc788\ub294 \uacbd\ud5d8\uc744 \uac00\uc9c4 \ucd5c\uace0\uc758 \uc804\ubb38\uac00\uc640 \ud611\ub825\ud558\ub294 \uac83\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p>\ud55c\uc0d8\uae00\ub85c\ubc8c\uc5d0\uc11c\ub294 \uc778\uc99d\ub41c \uc804\ubb38 \uc758\ub8cc \ubc88\uc5ed\uac00\uc640 \ud568\uaed8 <a 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