{"id":2401,"date":"2019-04-01T10:28:23","date_gmt":"2019-04-01T10:28:23","guid":{"rendered":"https:\/\/getprocert.com\/?page_id=2401"},"modified":"2026-02-24T12:24:27","modified_gmt":"2026-02-24T12:24:27","slug":"gpp-good-pharmacovigilance-practice","status":"publish","type":"page","link":"https:\/\/getprocert.com\/zh\/gpp-\u826f\u597d\u85e5\u7269\u8b66\u6212\u5be6\u52d9\/","title":{"rendered":"GPP (\u826f\u597d\u85e5\u7269\u8b66\u6212\u5be6\u52d9)"},"content":{"rendered":"

<\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>

\u826f\u597d\u85e5\u7269\u8b66\u6212\u898f\u7bc4 (GVP) - \u4fdd\u8b77\u6b50\u76df\u7684\u85e5\u7269\u5b89\u5168<\/span>\u826f\u597d\u85e5\u7269\u8b66\u6212\u5be6\u52d9<\/u> \u5be6\u8e10<\/b><\/span><\/span><\/h1>
\u8cfc\u8cb7 Good Pharmacovigilance Practice (GVP) \u8b49\u66f8\uff1f\u514d\u8a66\u53d6\u5f97\u539f\u59cb\u3001\u8a3b\u518a\u4e14\u6709\u6548\u7684 GVP \u8b49\u66f8\u3002\u9075\u5faa EMA \u5728\u6b50\u76df\u76e3\u63a7\u85e5\u7269\u5b89\u5168\u6027\u7684\u6e96\u5247\u3002\u7acb\u5373\u7dda\u4e0a\u8cfc\u8cb7 GVP \u8b49\u66f8\uff01<\/div><\/header>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/p>\n

\u7684 GPP \u8b49\u66f8 - \u826f\u597d\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5be6\u52d9 (GVP)<\/strong> \u5c0d\u65bc\u81f4\u529b\u65bc\u85e5\u54c1\u5b89\u5168\u8207\u6cd5\u898f\u76e3\u7763\u7684\u5c08\u696d\u4eba\u54e1\u800c\u8a00\uff0c\u9019\u662f\u4e00\u9805\u91cd\u8981\u7684\u8a8d\u8b49\u3002\u7531 \u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA)<\/strong>\u6b64\u8a8d\u8b49\u8b49\u5be6\u60a8\u5728\u8b58\u5225\u3001\u7ba1\u7406\u548c\u5831\u544a\u6574\u500b\u7522\u54c1\u751f\u547d\u9031\u671f\u5167\u7684\u85e5\u7269\u4e0d\u826f\u53cd\u61c9\u65b9\u9762\u7684\u5c08\u696d\u77e5\u8b58\uff0c\u4ee5\u78ba\u4fdd\u60a3\u8005\u5b89\u5168\u4ecd\u662f\u9996\u8981\u4efb\u52d9\u3002<\/p>\n

\u7531\u65bc\u6cd5\u898f\u8981\u6c42\u6301\u7e8c\u6f14\u9032\uff0c\u8a31\u591a\u5c08\u696d\u4eba\u58eb\u9078\u64c7 \u7dda\u4e0a\u8cfc\u8cb7 GPP \u8b49\u66f8<\/strong><\/a> \u4ee5\u7bc0\u7701\u6642\u9593\u548c\u7e5e\u904e\u50b3\u7d71\u7684\u8003\u8a66\u969c\u7919\u3002\u6211\u5011\u63d0\u4f9b\u5b89\u5168\u4e14\u6709\u6548\u7387\u7684\u65b9\u5f0f\u53d6\u5f97 \u771f\u5be6\u3001\u6709\u6548\u4e14\u5b8c\u6574\u8a3b\u518a\u7684 GPP \u8b49\u66f8<\/strong>\u5354\u52a9\u60a8\u5728\u85e5\u7269\u76e3\u6e2c\u3001\u6cd5\u898f\u4e8b\u52d9\u6216\u85e5\u7269\u5b89\u5168\u76e3\u63a7\u9818\u57df\u4fdd\u6301\u5408\u898f\u6027\uff0c\u4e26\u63d0\u5347\u60a8\u7684\u8077\u696d\u751f\u6daf\u3002<\/p>\n

\n<\/div>

<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/p>\n

\u7684 GPP<\/a> \u8a8d\u8b49 - \u826f\u597d\u85e5\u7269\u8b66\u6212\u5be6\u52d9<\/strong> \u662f\u6574\u500b\u6b50\u76df\u7684\u6cd5\u5f8b\u548c\u5c08\u696d\u8981\u6c42\uff0c\u78ba\u4fdd\u7b26\u5408 EMA\uff08\u6b50\u6d32\u85e5\u7269\u7ba1\u7406\u5c40\uff09<\/strong> \u85e5\u7269\u5b89\u5168\u6a19\u6e96\u3002\u6b64\u8cc7\u683c\u8b49\u66f8\u53ef\u8b49\u660e\u60a8\u5177\u5099\u76e3\u63a7\u3001\u8a55\u4f30\u548c\u5831\u544a\u85e5\u54c1\u4e0d\u826f\u53cd\u61c9\u7684\u5c08\u696d\u77e5\u8b58\uff0c\u9019\u662f\u4fdd\u8b77\u516c\u773e\u5065\u5eb7\u7684\u91cd\u8981\u8cac\u4efb\u3002<\/p>\n

\u8209\u884c \u6709\u6548\u3001\u8a3b\u518a\u7684 GPP \u8b49\u66f8<\/strong> \u986f\u793a\u60a8\u5c0d\u56b4\u683c\u85e5\u7269\u8b66\u6212\u898f\u7bc4\u7684\u627f\u8afe\uff0c\u4ee5\u53ca\u5728\u85e5\u7269\u751f\u547d\u9031\u671f\u4e2d\u7dad\u8b77\u5b89\u5168\u6027\u7684\u80fd\u529b\u3002\u96c7\u4e3b\u548c\u76e3\u7ba1\u6a5f\u69cb\u90fd\u975e\u5e38\u91cd\u8996\u9019\u9805\u8a8d\u8b49\uff0c\u56e0\u70ba\u5b83\u8b49\u5be6\u60a8\u6709\u80fd\u529b\u8b58\u5225\u98a8\u96aa\u3001\u57f7\u884c\u5b89\u5168\u63aa\u65bd\uff0c\u4e26\u5728\u81e8\u5e8a\u548c\u4e0a\u5e02\u5f8c\u74b0\u5883\u4e2d\u70ba\u8ca0\u8cac\u4efb\u7684\u85e5\u7269\u4f7f\u7528\u505a\u51fa\u8ca2\u737b\u3002 \u53d6\u5f97\u8b49\u66f8<\/strong><\/a><\/p>\n

\n<\/div><\/div><\/div><\/div><\/div>

<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
\"bt_bb_section_bottom_section_coverage_image\"<\/div><\/section>
<\/span><\/span><\/span><\/span><\/div><\/div>
\u958b\u555f\u60a8\u7684\u8077\u696d\u751f\u6daf<\/span><\/div>

\u66f4\u7f8e\u597d\u7684\u672a\u4f86<\/u>

\nGVP \u8b49\u66f8<\/b><\/span><\/span><\/h2>
\u6295\u8cc7\u65bc\u51fa\u552e\u7684\u771f\u6b63 GVP \u8b49\u66f8\u53ef\u80fd\u662f\u60a8\u8077\u696d\u751f\u6daf\u7684\u8f49\u6298\u6027\u4e00\u6b65\u3002\u4ee5\u4e0b\u662f\u4e00\u4e9b\u4e3b\u8981\u512a\u9ede\uff1a<\/div><\/header>
<\/p>\n
\n

\u5229\u7528\u4f4e\u5782\u7684\u679c\u5be6\uff0c\u627e\u51fa\u53ef\u9032\u884c beta \u6e2c\u8a66\u7684\u5927\u81f4\u589e\u503c\u6d3b\u52d5\u3002<\/p>\n<\/blockquote>\n

\n<\/div>

<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/span>

\u63d0\u5347\u60a8\u7684\u5c08\u696d\u516c\u4fe1\u529b<\/h4>
GVP \u8a3b\u518a\u8b49\u66f8\u53ef\u78ba\u7acb\u60a8\u5728\u85e5\u7269\u8b66\u6212\u65b9\u9762\u7684\u5c08\u5bb6\u5730\u4f4d\uff0c\u589e\u52a0\u96c7\u4e3b\u3001\u6cd5\u898f\u6a5f\u69cb\u548c\u540c\u4e8b\u5c0d\u60a8\u7684\u4fe1\u4efb\u3002\u9019\u7a2e\u8a8d\u53ef\u6709\u52a9\u65bc\u60a8\u5728\u7af6\u722d\u6fc0\u70c8\u7684\u88fd\u85e5\u884c\u696d\u4e2d\u812b\u7a4e\u800c\u51fa\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
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\u78ba\u4fdd\u7b26\u5408\u6cd5\u898f<\/h4>
\u53d6\u5f97 GVP \u539f\u5ee0\u8b49\u66f8\uff0c\u5373\u8b49\u660e\u60a8\u6709\u80fd\u529b\u9075\u5b88 EMA \u6307\u5f15\u4e26\u6709\u6548\u7ba1\u7406\u5b89\u5168\u98a8\u96aa\u3002\u9019\u7a2e\u5c08\u696d\u77e5\u8b58\u5c0d\u65bc\u7dad\u6301\u5408\u898f\u6027\u548c\u4fdd\u8b77\u516c\u773e\u5065\u5eb7\u81f3\u95dc\u91cd\u8981\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
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\u62d3\u5c55\u60a8\u7684\u4e8b\u696d\u6a5f\u6703<\/h4>
\u64c1\u6709\u6709\u6548\u7684 GVP \u8b49\u66f8\uff0c\u5c31\u80fd\u70ba\u60a8\u6253\u958b\u6b50\u76df\u5404\u570b\u54c1\u8cea\u4fdd\u8b49\u3001\u6cd5\u898f\u4e8b\u52d9\u548c\u85e5\u7269\u8b66\u6212\u7b49\u9818\u57df\u7684\u5927\u9580\u3002\u64c1\u6709\u56b4\u683c EMA \u6307\u5c0e\u65b9\u91dd\u7684\u570b\u5bb6\/\u5730\u5340\u7684\u96c7\u4e3b\u6703\u7a4d\u6975\u5c0b\u627e\u7d93\u904e\u8a8d\u8b49\u7684\u5c08\u696d\u4eba\u54e1\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
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\u7c21\u55ae\u5feb\u901f\u7684\u8a8d\u8b49\u7a0b\u5e8f<\/h4>
\u8a31\u591a\u5c08\u696d\u4eba\u58eb\u73fe\u5728\u8cfc\u8cb7 GVP \u8b49\u66f8\u6642\uff0c\u4e0d\u9700\u8981\u7d93\u904e\u8003\u8a66\u969c\u7919\uff0c\u7bc0\u7701\u6642\u9593\u7684\u540c\u6642\u4ecd\u80fd\u7372\u5f97\u8a8d\u53ef\u7684\u8b49\u66f8\u3002\u9019\u7a2e\u7121\u5f8c\u9867\u4e4b\u6182\u7684\u65b9\u5f0f\u53ef\u8b93\u60a8\u5c08\u6ce8\u65bc\u4e8b\u696d\u6210\u9577\u8207\u85e5\u7269\u76e3\u7763\u5be6\u52d9\u7684\u5be6\u969b\u61c9\u7528\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>
<\/p>\n

\u6295\u8cc7\u65bc\u60a8\u7684\u5c08\u696d\u767c\u5c55\uff0c\u8b93\u60a8\u7684\u8077\u696d\u751f\u6daf\u66f4\u4e0a\u4e00\u5c64\u6a13\u3002\u7acb\u5373\u7dda\u4e0a\u8cfc\u8cb7 Good Pharmacovigilance Practice \u8b49\u66f8\uff0c\u6210\u70ba\u6b50\u76df\u503c\u5f97\u4fe1\u8cf4\u7684\u85e5\u7269\u5b89\u5168\u5b88\u8b77\u8005\uff01<\/span><\/strong><\/em><\/p>\n

\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

\"bt_bb_section_bottom_section_coverage_image\"<\/div><\/section>
<\/div><\/div>
\u4e0d\u53ea\u662f\u8a8d\u8b49<\/span><\/div>

\u70ba\u4f55\u9078\u64c7\u6211\u5011

\n\u7533\u8acb\u88fd\u85e5\u696d\u8b49\u66f8\uff1f<\/b> <\/span><\/span><\/h2>
\u53d6\u5f97\u696d\u754c\u8a8d\u53ef\u7684\u88fd\u85e5\u8a8d\u8b49\uff0c\u8b93\u60a8\u5177\u5099\u63d0\u5347\u4e8b\u696d\u767c\u5c55\u7684\u6280\u80fd\u8207\u77e5\u8b58\uff0c\u5728\u7af6\u722d\u6fc0\u70c8\u7684\u5c31\u696d\u5e02\u5834\u4e2d\u812b\u7a4e\u800c\u51fa\u3002<\/div><\/header>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
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<\/span>
\u696d\u754c\u8a8d\u53ef<\/div>
\u6211\u5011\u7684\u8a8d\u8b49\u662f\u5168\u7403\u8a8d\u53ef\u7684\uff0c\u53ef\u63d0\u9ad8\u60a8\u5728\u88fd\u85e5\u696d\u7684\u53ef\u4fe1\u5ea6\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span>
\u6c92\u6709\u8003\u8a66\u58d3\u529b<\/div>
\u5728\u6c92\u6709\u8003\u8a66\u58d3\u529b\u7684\u60c5\u6cc1\u4e0b\u7372\u5f97\u8a8d\u8b49\uff0c\u5c08\u6ce8\u65bc\u5be6\u7528\u3001\u771f\u5be6\u7684\u77e5\u8b58\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span>
\u5c08\u5bb6\u6307\u5c0e<\/div>
\u6211\u5011\u7684\u8a8d\u8b49\u7531\u696d\u754c\u5c08\u5bb6\u8a2d\u8a08\uff0c\u78ba\u4fdd\u60a8\u7372\u5f97\u9ad8\u54c1\u8cea\u7684\u76f8\u95dc\u5167\u5bb9\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div><\/div><\/div>
<\/span>
\u5feb\u901f\u7c21\u4fbf\u7684\u6d41\u7a0b<\/div>
\u6211\u5011\u7684\u8a8d\u8b49\u7a0b\u5e8f\u7c21\u5316\u4e14\u6709\u6548\u7387\uff0c\u8b93\u60a8\u5feb\u901f\u7372\u5f97\u8a8d\u8b49\uff0c\u4e26\u958b\u59cb\u61c9\u7528\u60a8\u7684\u77e5\u8b58\u3002<\/div><\/div><\/div>
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\u8077\u6daf\u767c\u5c55<\/div>
\u6211\u5011\u7684\u8a8d\u8b49\u70ba\u60a8\u958b\u555f\u4e86\u901a\u5f80\u65b0\u8077\u696d\u6a5f\u6703\u7684\u5927\u9580\uff0c\u4e26\u5354\u52a9\u60a8\u5728\u7af6\u722d\u6fc0\u70c8\u7684\u88fd\u85e5\u696d\u5c31\u696d\u5e02\u5834\u4e2d\u812b\u7a4e\u800c\u51fa\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span>
\u6301\u7e8c\u652f\u63f4<\/div>
\u6211\u5011\u5728\u60a8\u7684\u8a8d\u8b49\u4e4b\u65c5\u4e2d\u63d0\u4f9b\u6301\u7e8c\u7684\u652f\u63f4\uff0c\u78ba\u4fdd\u60a8\u64c1\u6709\u6210\u529f\u6240\u9700\u7684\u6240\u6709\u8cc7\u6e90\u3002<\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>
\"bt_bb_section_bottom_section_coverage_image\"<\/div><\/section>
<\/span><\/span><\/span><\/span><\/div><\/div>
\u5ba2\u6236\u5fc3\u8072<\/span><\/div>

\u5049\u5927\u7684\u5ba2\u6236<\/u>

\n\u6975\u4f73\u8a55\u8ad6<\/b><\/span><\/span><\/h2>
\u6211\u5011\u7684\u88fd\u85e5\u696d\u5ba2\u6236\u8b9a\u63da\u6211\u5011\u7684\u8a8d\u8b49\u8b49\u66f8\u5177\u6709\u5be6\u7528\u6027\uff0c\u4e26\u80fd\u4fc3\u9032\u8077\u6daf\u767c\u5c55\u3002\u8a31\u591a\u4eba\u5f37\u8abf\u6240\u5b78\u5230\u7684\u6280\u80fd\u5982\u4f55\u5e6b\u52a9\u4ed6\u5011\u5728\u8077\u5834\u4e0a\u812b\u7a4e\u800c\u51fa\uff0c\u7372\u5f97\u5c08\u696d\u767c\u5c55\u3002<\/div><\/header>
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\u6700\u4f73\u5c08\u5bb6<\/b><\/span><\/span><\/h4>
GLP \u8a8d\u8b49\u8b93\u6211\u5177\u5099\u4e86\u57f7\u884c\u66f4\u6709\u6548\u3001\u66f4\u5408\u898f\u7684\u5be6\u9a57\u5ba4\u7a0b\u5e8f\u7684\u77e5\u8b58\uff0c\u78ba\u4fdd\u6211\u5011\u7684\u7814\u7a76\u7dad\u6301\u5728\u9802\u5c16\u6c34\u5e73\u3002<\/div><\/header>
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\u5f35\u9e97\u8389<\/span><\/div><\/header>
<\/span><\/span><\/span><\/span><\/div><\/div><\/div><\/div>
<\/span><\/span><\/span><\/span><\/div><\/div>

\u6700\u9069\u5408\u6211\u7684\u4eba<\/b><\/span><\/span><\/h4>
GMP \u8a8d\u8b49\u70ba\u6211\u63d0\u4f9b\u4e86\u5bf6\u8cb4\u7684\u88fd\u9020\u5be6\u52d9\u77e5\u8b58\uff0c\u76f4\u63a5\u6539\u5584\u4e86\u6211\u5011\u7684\u751f\u7522\u6d41\u7a0b\u548c\u5408\u898f\u6027\u3002<\/div><\/header>
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JUSTIN EMERSON<\/span><\/div><\/header>
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\u5b8c\u5168\u6b63\u78ba\uff01<\/b><\/span><\/span><\/h4>
\u826f\u597d\u5206\u92b7\u898f\u7bc4\u8a8d\u8b49\u6539\u8b8a\u4e86\u85e5\u54c1\u5206\u92b7\u7ba1\u7406\u7684\u904a\u6232\u898f\u5247\uff0c\u65e2\u80fd\u78ba\u4fdd\u7b26\u5408\u6cd5\u898f\uff0c\u53c8\u80fd\u63d0\u9ad8\u71df\u904b\u6548\u7387\u3002<\/div><\/header>
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joanna prestley<\/span><\/div><\/header>
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\u6700\u68d2\u7684\u6c7a\u5b9a<\/b><\/span><\/span><\/h4>
\u53d6\u5f97 GDP \u8a8d\u8b49\u7d66\u4e86\u6211\u4fe1\u5fc3\u548c\u6280\u80fd\uff0c\u8b93\u6211\u80fd\u78ba\u4fdd\u5b89\u5168\u3001\u5408\u898f\u5730\u914d\u9001\u85e5\u54c1\u3002<\/div><\/header>
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BRADLEY SMITH<\/span><\/div><\/header>
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\"bt_bb_section_bottom_section_coverage_image\"<\/div><\/section>
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\u8f15\u9b06\u806f\u7d61\u6211\u5011<\/span>\u9032\u5165<\/b> \u89f8\u6478<\/u><\/span><\/span><\/h2>
\u7acb\u5373\u8207\u6211\u5011\u806f\u7e6b\uff0c\u63a2\u7d22\u6211\u5011\u7684\u88fd\u85e5\u884c\u696d\u8a8d\u8b49\uff0c\u63d0\u5347\u60a8\u7684\u5c08\u696d\u77e5\u8b58\u3002<\/div><\/header>
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\u5730\u5740<\/u><\/div>
Bloomsbury Square\u3001

\n\u502b\u6566 WC1B 4EA<\/div><\/div><\/div>
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\u806f\u7d61\u6211\u5011<\/u><\/div>
+1 123 456 7897<\/div><\/div><\/div>
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\u96fb\u90f5\u7d66\u6211\u5011<\/u><\/div>
contact@getprocert.com<\/div><\/div><\/div>
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