{"id":161049,"date":"2017-10-31T18:51:49","date_gmt":"2017-11-01T01:51:49","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/%e7%99%bd%e7%9a%ae%e4%b9%a6\/"},"modified":"2021-04-21T23:36:47","modified_gmt":"2021-04-22T06:36:47","slug":"%e7%99%bd%e7%9a%ae%e4%b9%a6","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e7%99%bd%e7%9a%ae%e4%b9%a6\/","title":{"rendered":"\u767d\u76ae\u4e66"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2017\/10\/resources-banner.jpg” saved_tabs=”all”][et_pb_fullwidth_header button_one_text=”\u56de\u5230\u77e5\u8bc6\u5e93” button_one_url=”\/knowledge-vault\/” _builder_version=”4.5.3″ title_font=”||||||||” title_text_color=”#ffffff” content_font=”||||||||” content_font_size=”20px” subhead_font=”PT Sans|700|||||||” subhead_font_size=”54px” subhead_line_height=”1.2em” background_color=”rgba(0,0,0,0.38)” custom_button_one=”on” button_one_text_size=”11″ button_one_icon=”%%41%%” button_one_icon_placement=”left” button_one_on_hover=”off” hover_enabled=”0″ button_one_letter_spacing_hover=”2″ button_one_text_size__hover_enabled=”off” button_two_text_size__hover_enabled=”off” button_one_text_color__hover_enabled=”off” button_two_text_color__hover_enabled=”off” button_one_border_width__hover_enabled=”off” button_two_border_width__hover_enabled=”off” button_one_border_color__hover_enabled=”off” button_two_border_color__hover_enabled=”off” button_one_border_radius__hover_enabled=”off” button_two_border_radius__hover_enabled=”off” button_one_letter_spacing__hover_enabled=”on” button_one_letter_spacing__hover=”2″ button_two_letter_spacing__hover_enabled=”off” button_one_bg_color__hover_enabled=”off” button_two_bg_color__hover_enabled=”off”]<\/p>\n

\u533b\u5b66\u7ffb\u8bd1\u8d44\u6599<\/h6>\n

\u767d\u76ae\u4e66<\/h1>\n

\u7814\u7a76\u56f4\u7ed5\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u7684\u72ec\u7279\u6311\u6218\u548c\u95ee\u9898<\/p>\n

[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”20px|0px|0|0px|false|false” locked=”off”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|10px|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”]<\/p>\n

[divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb]<\/p>\n

[\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/03\/the-eu-mdr-labelling-journey.jpg” title_text=”the-eu-mdr-labelling-journey” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center” hover_enabled=”0″ alt=”EU MDR white paper”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

\u6b27\u76df M D R \u6807\u7b7e \uff1a<\/h2>\n

\u6700\u65b0\u7684\u533b\u7597\u5668\u68b0\u6807\u7b7e\u8981\u6c42\u6307\u5357<\/h3>\n

2017 \u5e74 5 \u6708 26 \u65e5\uff0c\u6b27\u76df\u533b\u7597\u5668\u68b0\u6761\u4f8b 2017\/745\uff08\u6b27\u76df MDR\uff09\u6b63\u5f0f\u751f\u6548\uff0c\u81f4\u4f7f\u6b27\u76df\u7684\u76d1\u7ba1\u683c\u5c40\u53d1\u751f\u4e86\u91cd\u5927\u8f6c\u53d8\u3002<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/zh-hans\/the-eu-mdr-labelling-journey\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_color_all=”#dddddd” border_width_bottom=”1px” border_color_bottom=”#eeeeee” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/06\/qwality-not-included.jpg” title_text=”qwality-not-included” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

‘Qwality’ Not Included<\/h2>\n

The ability to rate translation quality in an effective and uniform manner has long been a requirement of the industry, but is also crucial to high-risk projects such as translation for patient safety medical device labelling.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/qwality-not-included\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/06\/a-new-era-of-patient-centricity.jpg” title_text=”a-new-era-of-patient-centricity” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center” hover_enabled=”0″ alt=”Patient centricity white paper”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

A New Era of Patient-Centricity<\/h2>\n

Patient-centricity has become one of the new catch phrases of the pharmaceutical industry. Indeed, although the industry appears to have patient-centricity in its DNA, the voices of the patients can easily get lost in all the hundreds of details in the drug development process.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/a-new-era-of-patient-centricity\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/09\/China-s-Ambitious-Path-Towards-Universal-Health-Coverage-1.jpg” title_text=”China-s-Ambitious-Path-Towards-Universal-Health-Coverage-1″ _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

China’s Ambitious Path Towards Universal Health Coverage (UHC)<\/h2>\n

In the last publication of CSOFT’s series on China’s healthcare reforms, the topic of how China’s radical regulatory makeover is shaking the entire pharmaceutical industry, both globally and domestically, was discussed.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/china-ambitious-path-towards-universal-health-coverage\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/09\/ENSURING-QUALITY-IN-A-STRATEGIC-MEDICAL-WRITING-PARTNERSHIP-1.jpg” title_text=”ENSURING-QUALITY-IN-A-STRATEGIC -MEDICAL-WRITING-PARTNERSHIP-1″ _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center” hover_enabled=”0″ alt=”Strategic partnership white paper”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

Ensuring Quality In A Strategic Medical Writing Partnership<\/h2>\n

We are talking about two things here \u2013 quality, and medical writing \u2013 so first let\u2019s examine both of these terms.Quality really means different things to different people \u2013 some consider it to be a degree of excellence, while others may see it as \u2018being fit for purpose\u2019. While perfection would be desired, it is always important to balance effort against output. Hence, rather than targeting perfection, it is important to focus on what matters: those critical data points that will make all the difference.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/ensuring-quality-in-a-strategic-medical-writing-partnership\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/06\/cfda-changes-pharma-industry.jpg” title_text=”cfda-changes-pharma-industry” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

How The NMPA Is Changing The Chinese Pharmaceutical Industry<\/h2>\n

Since 2015, the NMPA (CFDA) has initiated a series of reform documents, with the purpose of pushing the Chinese pharmaceutical and medical device industry to a more mature and globalized environment.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/cfda-changes-pharma-industry\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/06\/ectd-submission.jpg” title_text=”ectd\u63d0\u4ea4” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

How To Get Ready For eCTD Submission?<\/h2>\n

China is currently recognized as the world second largest pharmaceutical market. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/ectd-submission\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”4.5.3″ border_width_bottom=”1px” border_color_bottom=”#dddddd” use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/06\/translation-memory-maintenance.jpg” title_text=”translation-memory-maintenance” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

The Ins and Outs of Translation Memory Maintenance<\/h2>\n

Translation memory is a vital part of your business’s assets. As your business experiences change and grow, your TM will expand as well. In an ideal situation, it should continuously learn your company’s multilingual content and improve itself to provide you with efficiency, accuracy, and low costs that are necessary for successful globalization. Whereas in reality, it often collects and stores unwanted data.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/translation-memory-maintenance\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ use_custom_width=”on”][et_pb_column type=”1_3″ _builder_version=”4.5.3″ _module_preset=”default”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2021\/01\/medical-device-market.jpg” title_text=”medical-device-market” url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/medical-device-market-overview\/” _builder_version=”4.5.3″ _module_preset=”default” width=”70%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]<\/p>\n

\u4e9a\u6d32\u533b\u7597\u5668\u68b0\u5e02\u573a\u6982\u51b5\u548c\u76d1\u7ba1\u683c\u5c40<\/h2>\n

\u968f\u7740\u4e9a\u6d32\u5730\u533a\u7ecf\u6d4e\u7684\u589e\u957f\uff0c\u533b\u7597\u5065\u5eb7\u9886\u57df\u652f\u51fa\u4e0d\u65ad\u589e\u52a0\uff0c\u5f3a\u6709\u529b\u7684\u76d1\u7ba1\u6539\u9769\u4e5f\u7a33\u6b65\u8fdb\u884c\uff0c\u4e9a\u6d32\u5fc5\u5c06\u6210\u4e3a\u5168\u7403\u533b\u7597\u5668\u68b0\u516c\u53f8\u7684\u4e0b\u4e00\u4e2a\u70ed\u70b9\u533a\u57df\u3002\u672c\u767d\u76ae\u4e66\u5c06\u8be6\u7ec6\u5206\u6790\u4e9a\u6d32\u5730\u533a\u4e03\u4e2a\u4e3b\u8981\u533b\u7597\u5668\u68b0\u5e02\u573a\uff08\u4e2d\u56fd\uff0c\u65e5\u672c\uff0c\u97e9\u56fd\uff0c\u6fb3\u5927\u5229\u4e9a\uff0c\u9a6c\u6765\u897f\u4e9a\uff0c\u6cf0\u56fd\u548c\u5370\u5ea6\uff09\u7684\u5e02\u573a\u524d\u666f\u548c\u76d1\u7ba1\u683c\u5c40\u3002<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/lifesciences.csoftintl.com\/whitepapers\/medical-device-market-overview\/” button_text=”\u4e0b\u8f7d” _builder_version=”4.5.3″ _module_preset=”default” custom_padding=”||||false|false”][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=&#822 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false},"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/pages\/161049"}],"collection":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=161049"}],"version-history":[{"count":0,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/pages\/161049\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=161049"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}