涓轰簡杩涗竴姝ユ彁楂樻垜鍥藉尰鐤楀伐浣滆呬复搴婄鐮旇兘鍔涳紝淇冭繘涓村簥璇曢獙鐨勯珮璐ㄩ噺鍙戝睍锛岃仛鐒︽垜鍥芥棭鏈熶复搴婅瘯楠屼腑鐨勯渶姹傚拰闅鹃锛屾惌寤轰复搴婄爺绌惰呬笌涓氬唴涓撲笟浜哄+瀛︽湳浜ゆ祦骞冲彴锛屼腑鍥借嵂鐞嗗浼氳嵂鐗╀复搴婅瘯楠屼笓涓氬鍛樹細鍜岃嫃宸炲競涓タ鍖荤粨鍚堝浼氫复搴婅嵂瀛︿笓涓氬鍛樹細鎷熶簬2024骞6鏈20鏃ヨ嚦21鏃ュ湪鑻忓窞涓惧姙鈥滆嵂鐗╁強鍖荤枟鍣ㄦ涓村簥璇曢獙璐ㄩ噺绠$悊鑳藉姏鎻愬崌鍩硅鐝濄 
	鍩硅灏嗛個璇峰浗鍐呭鐭ュ悕鐨勪复搴婅瘯楠屼笓瀹躲佸鑰呮満鏋勪唬琛ㄧ瓑鍢夊鍑哄腑锛屽洿缁曚复搴婅瘯楠岀殑娉曡銆佹祦绋嬨佷鸡鐞嗐佹暟鎹鐞嗐佽川閲忔帶鍒剁瓑鏂归潰杩涜娣卞叆鎺㈣涓村簥璇曢獙棰嗗煙鐨勬渶鏂板彂灞曡秼鍔挎妧鏈垱鏂板拰瀹炶返搴旂敤锛屽垎浜粬浠湪涓村簥璇曢獙棰嗗煙鐨勭爺绌舵垚鏋滃拰瀹炶返缁忛獙銆傛澶栵紝杩樺皢鎻愪緵涓板瘜鐨勬渚嬪垎鏋愬拰浜掑姩浜ゆ祦鏈轰細锛屼笌浠栦滑杩涜闈㈠闈㈢殑浜ゆ祦浜掑姩銆佸垎浜粡楠屻佹帰璁ㄥ洶鎯戯紝鍏卞悓鎺ㄥ姩涓村簥璇曢獙棰嗗煙鐨勫彂灞曪紝鎻愰珮涓村簥璇曢獙绠$悊姘村钩鍜岀爺绌惰川閲忋傛湰娆″煿璁敱涓浗鑽悊瀛︿細鑽墿涓村簥璇曢獙涓撲笟濮斿憳浼氥佽嫃宸炲競涓タ鍖荤粨鍚堝浼氫复搴婅嵂瀛︿笓涓氬鍛樹細鍏变富鍔烇紝鑻忓窞甯傜珛鍖婚櫌鎵垮姙銆 
	涓銆佸熀鏈俊鎭 
	1.鍩硅鏃堕棿锛2024骞6鏈20鏃8:20鑷6鏈21鏃11:30 
	2.鍩硅鍦扮偣锛氬崡浜尰绉戝ぇ瀛﹀鑻忓闄簲妤兼姤鍛婂巺锛堣嫃宸炲競濮戣嫃鍖哄弻濉琛楅亾鍗佹琛458鍙凤級 
	3.鍩硅瀵硅薄锛氬尰鐤楁満鏋勩佷紒涓氥佺鐮旈櫌鏍$瓑浠庝簨鑽墿/鍖荤枟鍣ㄦ涓村簥璇曢獙鐩稿叧浜哄憳 
	4.鍩硅褰㈠紡锛氱嚎涓嬮潰鎺堛佽璁轰氦娴+绾夸笂鍩硅 
	浜屻佺粍缁囨満鏋 
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	鑻忓窞甯備腑瑗垮尰缁撳悎瀛︿細 
	鎵垮姙鍗曚綅锛氳嫃宸炲競绔嬪尰闄 
	涓夈佹棩绋嬪畨鎺 
	
		
			
				| 
					 
						鏃堕棿 
					 
				 | 
				
					 
						鍐呭 
					 
				 | 
				
					 
						鎺堣 
					 
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						06鏈20鏃ヤ笂鍗 
					 
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				| 
					 
						08:20-08:30 
					 
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						寮骞曞紡 
					 
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						鍖婚櫌棰嗗 
					 
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				| 
					 
						08:30-09:15 
					 
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						濡備綍鍋氫竴鍚嶅悎鏍肩殑鐮旂┒鑰 
					 
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						璧电涓 
					 
					
						棣栭兘鍖荤澶у闄勫睘鍖椾含鍚屼粊鍖婚櫌 
					 
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						09:15-10:00 
					 
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						鍖荤枟鍣ㄦ琛屼笟鍙戝睍鐜扮姸鍙婄爺绌惰呭垱鏂板垱涓氱殑鎬濊 
					 
				 | 
				
					 
						濮滃嘲 
					 
					
						涓浗鍖荤枟鍣ㄦ琛屼笟鍗忎細 
					 
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						10:00-11:00 
					 
				 | 
				
					 
						鏃ユ湰涓村簥璇曢獙鏈烘瀯瀵规棭鏈熶复搴婅瘯楠岀殑椋庨櫓鎶婃帶涓庤川閲忕鐞 
					 
					
						Risk Control and Quality Management of Early Phase Trial in
  Japanese Sites 
					 
				 | 
				
					 
						闄嶆棗璋︿竴 
					 
					
						Kenyichi Furihata 
					 
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				| 
					 
						11:00-11:45 
					 
				 | 
				
					 
						鐮旂┒鏈烘瀯濡備綍鎵ц鍥介檯澶氫腑蹇冧复搴婅瘯楠岀殑鎵ц涓庤川閲忔妸鎺 
					 
					
						How to implementation MRCT and Quality control in
  investigational site 
					 
				 | 
				
					 
						钀╂晱鏃 
					 
					
						Toshiaki Hagi 
					 
				 | 
			
			
				| 
					 
						06鏈20鏃ヤ笅鍗 
					 
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				| 
					 
						13:30-14:15 
					 
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						鍩轰簬椋庨櫓鐨勬棭鏈熶复搴婅瘯楠岃繍钀ョ鐞 
					 
				 | 
				
					 
						瀛欏崕榫 
					 
					
						鑻忓窞绉戞灄鍒╁悍鍖昏嵂绉戞妧鏈夐檺鍏徃 
					 
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				| 
					 
						14:15-15:00 
					 
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						銆婅嵂鐗╀复搴婅瘯楠屾満鏋勭洃鐫f鏌ヨ鐐广嬭В璇 
					 
				 | 
				
					 
						璧电考 
					 
					
						鏃犻敗甯備汉姘戝尰闄 
					 
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				| 
					 
						15:00-15:45 
					 
				 | 
				
					 
						涓村簥璇曢獙鏂囦欢鍙楁帶鐨勫叧閿棶棰 
					 
				 | 
				
					 
						钂嬭悓 
					 
					
						姹熻嫃鐪佷腑鍖婚櫌 
					 
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				| 
					 
						15:45-16:30 
					 
				 | 
				
					 
						鐮旂┒鑰呭彂璧风殑涓村簥鐮旂┒瀹炴柦瑕佺偣 
					 
				 | 
				
					 
						鍛ㄧ剷 
					 
					
						铓屽煚鍖荤澶у绗竴闄勫睘鍖婚櫌 
					 
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						06鏈21鏃ヤ笂鍗 
					 
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				| 
					 
						08:30-09:15 
					 
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						涓村簥璇曢獙娉曞緥椋庨櫓鍙婂悎瑙勮鐐 
					 
				 | 
				
					 
						娌 鏅 涓 
					 
					
						鍖椾含甯傚ぉ鍏冿紙鑻忓窞锛夊緥甯堜簨鍔℃墍 
					 
				 | 
			
			
				| 
					 
						09:15-10:00 
					 
				 | 
				
					 
						涓村簥璇曢獙鏍告煡涓殑浼︾悊鐩稿叧闂 
					 
				 | 
				
					 
						鍗庨洴濡 
					 
					
						鑻忓窞澶у闄勫睘绗簩鍖婚櫌 
					 
				 | 
			
			
				| 
					 
						10:00-10:45 
					 
				 | 
				
					 
						浠庣爺绌惰呯殑瑙掑害鐪嬭嵂鐗╀复搴婅瘯楠屼腑鐨勮川閲忕鐞 
					 
				 | 
				
					 
						闄堣暰 
					 
					
						鑻忓窞甯傜珛鍖婚櫌 
					 
				 | 
			
			
				| 
					 
						10:45-11:30 
					 
				 | 
				
					 
						鍖荤枟鍣ㄦ涓村簥璇曢獙椤圭洰瀹炴柦闂瑙f瀽锛堜互姘村厜閽堜负渚嬶級 
					 
				 | 
				
					 
						闄堣瘹 
					 
					
						鑻忓窞甯傜珛鍖婚櫌 
					 
				 | 
			
		
	
 
	鍥涖佹姤鍚嶅強璐圭敤缂寸撼 
	1.鎶ュ悕鏂瑰紡锛 
	锛1锛绾夸笅鍩硅瀛﹀憳浣跨敤寰俊鎵弿涓嬫柟浜岀淮鐮侊紝濉啓鎶ュ悕淇℃伅锛堟墍濉啓淇℃伅鐢ㄤ簬GCP璇佷功鍒朵綔锛岃鍔″繀濉啓姝g‘锛夛紝鍚嶉鏈夐檺锛屾寜缂磋垂椤哄簭鎺掑簭锛屾姤鍚嶆埅姝㈡椂闂2024骞6鏈19鏃ャ 
	 
	 
	
 
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	2锛庡煿璁璐圭敤 
	锛1锛夌嚎涓嬪強绾夸笂鏀惰垂鏍囧噯鍧囦负500鍏/浜猴紙鍚嚎涓嬪煿璁湡闂村崍椁愯垂銆佽瘉涔﹀埗浣滆垂绛夛級銆傚煿璁湡闂翠氦閫氥佷綇瀹胯垂鑷悊銆傚涓嶉渶瑕佸煿璁瘉涔﹀強瀛﹀垎鐨勫鍛樼嚎涓婄嚎涓嬪潎鍙厤璐瑰惉璇俱 
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	璐﹀彿锛1102170509008162925 
	寮鎴疯锛氫腑鍥藉伐鍟嗛摱琛岃偂浠芥湁闄愬叕鍙歌嫃宸炴钵娴柊鍩庢敮琛 
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	锛3锛夎鍦2024骞6鏈19鏃ヤ箣鍓嶏紙鍚綋澶╋級瀹屾垚缂磋垂銆 
	3锛庡煿璁瘉涔﹀強鍙戠エ棰嗗彇 
	锛1锛夊弬浼氫汉鍛橈紙浠呴檺绾夸笅鍙備細锛夌鍚堣姹傝咃紝鍙幏寰椻叀绫诲鍒嗚瘉涔︼紙鑻忓窞甯傜户缁暀鑲查」鐩紝椤圭洰缂栧彿锛SQ20231191锛夋暟閲忔湁闄愶紝鎸夎冭瘯鎴愮哗鎺掑悕鍙戞斁銆 
	锛2锛夌嚎涓嬪強绾夸笂鍙備細瀛﹀憳缂磋垂鎴愬姛鍚庡畬鎴愬煿璁椂闀垮苟鑰冭瘯鍚堟牸鑰咃紝鍙戞斁涓浗鑽悊瀛︿細鑽墿涓村簥璇曢獙涓撲笟濮斿憳浼氶鍙戠殑GCP鐢靛瓙璇佷功銆 
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	锛3锛夊闇寮绁紝璇峰湪缂磋垂鍚庡叧娉ㄢ滆嫃宸炲競绔嬪尰闄GCP鈥濆叕浼楀彿锛屽洖澶嶁滃紑绁ㄢ濓紝姝g‘濉啓鍙戠エ寮绁ㄤ俊鎭紙鎴鑷2024骞6鏈23鏃ワ級锛屽彂绁ㄥ湪浼氳缁撴潫鍚2鍛ㄥ唴閫氳繃閭欢鍙戦併 
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	涓浗鑽悊瀛︿細鑽墿涓村簥璇曢獙涓撲笟濮斿憳浼  
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	2024骞5鏈29鏃