approval for registration of new material in Kingdee
外企注册指南Guidance on Registration
Guidance on RegistrationDocuments(one copy for each) for name approval application of foreign (including Hong Kong, Taiwan and Macao) invested enterprises1. The "application for name pre-approval of foreign invested enterprises" signed by all investors; 全体投资人签署的《外商投资企业名称预先核准申请书》；2. Photocopies of qualification certificates of all investors; 全体投资人的资格证明复印件；3. Other relevant documents and certificates; 其他有关文件、证件；Documents for registration of establishment of a Foreign-, Hong Kong-, Macao- or Taiwan-Invested enterprise (one copy for each)For registration of establishment of a Foreign-Invested company1、"The establishment registration application Form for foreign invested Enterprises" by the legal representative to be appointed 拟任法定代表人签署的《外商投资的公司设立登记申请书》2、The approval document issued by the approval authority (one duplicate of official reply and approval certificate); 审批机关的批准文件（批复和批准证书副本1）3、Articles of association公司章程4、The notification of name pre-approval 《名称预先核准通知书》5、Proof of subject qualification or proof of identification as a natural person for investors 投资者的主体资格证明或自然人身份证明6、Photocopies of documents of appointment and proof of identification for directors, supervisors and managers董事、监事和经理的任职文件及身份证明复印件7、Photocopies of documents of appointment and proof of identification for legal representative 法定代表人任职文件和身份证明复印件8、Investment verification certificates issued by a legally established investment verification authority依法设立的验资机构出具的验资证明9、Where a shareholder has made his/her capital contribution with nom-currency properties for the first time, documents proving the completion of property transfer procedures shall be submitted.股东首次出资是非货币财产的，提交已办理财产权转移手续的证明文件10、Certificate of company domicile公司住所证明11、The minutes of the inaugural assembly;创立大会的会议记录12、Pre-approval document or certificate;前置审批文件或证件13、Letter of authorization for service of legal documents 法律文件送达授权委托书14、Other relevant documents and certificates;其它有关文件For registration of establishment of a Foreign-Invested enterprise (non-company)1、"The application from signed by the pending legal representative";拟任法定代表人签署的《（非公司）外商投资企业设立登记申请书》2、The approval document issued by the approval authority (one duplicate of official reply and approval certificate);审批机关的批准文件（批复和批准证书副本1）3、Contract and articles of association; 合同、章程4、"The notification of name pre-approval" 名称预先核准通知书5、Investor's legal business certificate and credit certificate;投资者的合法开业证明和资信证明6、Photocopies of documents of appointment and proof of identification for legal representative and members of Joint management committee法定代表人、联合管理委员会委员任职文件原件及身份证明复印件7、The certificate of using the new domicile;住所使用证明8、Investment verification certificates issued by a legally established investment verification authority依法设立的验资机构出具的验资证明9、Pre-approval document or certificate;前置审批文件或证件10、Other relevant documents and certificates;其它有关文件For registration of cancellation of a Foreign-Invested company1、"The cancellation registration application form for foreign invested enterprises" signed by the responsible person of the liquidation team 清算组负责人签署的《外商投资的公司注销登记申请书》2、The approval document issued by the original approval authority agreeing the cancellation; 原审批机关同意注销的批准文件3、Resolution or decision made in accordance with laws依法作出的决议或者决定4、Liquidation report that has been recorded and confirmed in accordance with laws经依法备案、确认的清算报告5、Certificate for registration of cancellation issued by taxation and customs authorities税务和海关部门出具的完税证明6、Certificate for registration of cancellation of branches分公司的注销登记证明7、The original and the duplicate business license营业执照正、副本8、Other relevant documents and certificates;其它有关文件For registration of cancellation of a Foreign-Invested enterprise (non-company)1、"The cancellation registration application form for foreign invested enterprises";2、The approval document issued by the original approval authority agreeing the cancellation;3、Resolution or decision made in accordance with laws4、Reports confirming the settlement of credits and liabilities or documents formulated by liquidation team that are responsible for settlement of credits and liabilities5、Duty-paid certificates issued by taxation authority and customs;6、Certificates showing cancellation of its branches (administrative offices);7、The original and the duplicate business license, as well as the official stamp8、Other relevant documents and certificates《外商投资企业注销登记申请书》2、原审批机关同意注销的批准文件3、依法作出的决议或决定4、清理债权债务完结的报告或者清算组织负责清理债权债务的文件5、税务和海关出具的完税证明6、分支（办事）机构已注销的证明7、营业执照正、副本和公章8、其它有关文件Cancellation of modification registration of foreign invested enterprises1. "Application Form for Cancellation of Modification Registration of Foreign Invested Enterprises" signed by the legal representative of the company;2. Written judgment of the people's court;3. The former approval letter for the application of modification registration;4. Photocopy of the duplicate of the business license;5. Other relevant documents;The modification (for record) registration application form for foreign invested enterprisesModification of company name1、"The modification (for record) registration application form for foreign invested enterprises";2、Resolution or decision made in accordance with laws3、The photocopy of the duplicate of the business license4、The notification of name pre-approval;5、The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;6、Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、依法作出的决议或决定3、营业执照副本复印件4、名称变更核准通知书5、公司法定代表人签署的公司章程修正案或修改后的公司章程6、其他有关文件Modification of company domicile1. "The modification (for record) registration application form for foreign invested enterprises";2、Resolution or decision made in accordance with laws3、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative4、The certificate of using the new domicile;5、The photocopy of the duplicate of the business license6、Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、依法作出的决议或决定3、公司法定代表人签署的公司章程修正案或修改后的公司章程4、住所使用证明5、营业执照副本复印件6、其他有关文件Modification of the legal representative1、"The modification (for record) registration application form for foreign invested enterprises";2、Resolution or decision made in accordance with laws3、The appointment document of the new legal representative and the dismissal document of the former legal representative;4、The registration form of the new legal representative;5、The photocopy of the duplicate of the business license6、The approval document issued by the approval authority;7、Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、依法作出的决议或决定3、原法定代表人的免职文件和新任法定代表人的任职文件4、新任法定代表人登记表5、营业执照副本复印件6、审批机关的批准文件7、其它有关文件Modification of gross investment and registered capital1. "The modification (for record) registration application form for foreign invested enterprises";2. Approval document and certificate issued by the approval authority (one duplicate);3、Resolution or decision made in accordance with laws4、The modification agreement for contract and articles of association;5、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative6、Investment verification certificates issued by a legally established investment verification authority7、Sample newspaper that publishes the capital reduction announcement and debt repayment report or debt assurance certificate8、The photocopy of the duplicate of the business license9、Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、审批机关的批准文件（批复和批准证书副本1）3、依法作出的决议或决定4、合同、章程的修改协议5、公司法定代表人签署的公司章程修正案或修改后的公司章程6、依法设立的验资机构出具的验资证明7、刊登减资公告的报纸报样及债务清偿报告或债务担保证明8、营业执照副本复印件9、其它有关文件Modification of the paid-in registered capital1. "The modification (for record) registration application form for foreign invested enterprises";2. Certificate of investment verification issued by an investment verification entity established according to the law;3. Photocopy of the duplicate of the business license;4. Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、依法设立的验资机构出具的验资证明3、营业执照副本复印件4、其它有关文件Modification of time and forms of investment (new investment)1. "The Modification (for record) Registration Application Form for Foreign Invested Enterprises" signed by the legal representative of the company;2. Approval document issued by the approval authority (one duplicate of the official reply and the approval certificate);3. Resolution or decision made according to the law;4. The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5. Photocopy of the duplicate of the business license;6. Other relevant documents;1、公司法定代表人签署的《外商投资的公司变更（备案）登记申请书》2、审批机关的批准文件(批复和批准证书副本1）3、依法作出的决议或决定4、公司法定代表人签署的公司章程修正案或修改后的公司章程5、营业执照副本复印件6、其它有关文件Modification of business period1. "The modification (for record) registration application form for foreign invested enterprises";2. Approval document and certificate issued by the approval authority (one duplicate);3、Resolution or decision made in accordance with laws4. The modification agreement for contract and articles of association;5、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative6、The photocopy of the duplicate of the business license7、Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、审批机关的批准文件（批复和批准证书副本1）3、依法作出的决议或决定4、合同、章程的修改协议5、公司法定代表人签署的公司章程修正案或修改后的公司章程6、营业执照副本复印件7、其它有关文件Modification of business scope1. 1. "The modification (for record) registration application form for foreign invested enterprises";2. Approval document issued by the approval authority (one duplicate of the official reply and the approval certificate);3. Resolution or decision made according to the law;4. The modification agreement for contract and articles of association;5. The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;6. Photocopy of the duplicate of the business license;7. Prior approval documents or certificates;8. Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、审批机关的批准文件（批复和批准证书副本1）3、依法作出的决议或决定4、合同、章程的修改协议5、公司法定代表人签署的公司章程修正案或修改后的公司章程6、营业执照副本复印件7、前置审批文件或证件8、其他有关文件Modification of share ownership1、"The modification (for record) registration application form for foreign invested enterprises";2、Approval document and certificate issued by the approval authority (one duplicate);3、Resolution or decision made according to the law;4、The modification agreement for contract and articles of association;5、The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;6、The share transfer agreement;7、Statement acquiring the approval of other investors to allow the transfer in accordance with laws8、The proof of subject qualification of the transferee;9、Certificate of financial standing of the transferee;10、Letter of attorney for the serving of legal documents;11、The photocopy of the duplicate of the business license12、Other relevant documents;1、外商投资企业变更（备案）登记申请书2、审批机关的批准文件（批复和批准证书副本1）3、依法作出的决议或决定4、合同、章程的修改协议5、公司法定代表人签署的公司章程修正案或修改后的公司章程6、股权转让协议7、依法经其他投资方同意转让的声明8、股权受让方的主体资格证明9、股权受让方的资信证明10、法律文件送达授权委托书11、营业执照副本复印件12、其它有关文件Modification of investor name1. "The modification (for record) registration application form for foreign invested enterprises";2. Approval document issued by the approval authority (one duplicate of the official reply and the approval certificate);3. Evidentiary documents for modification of investor name;4. The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5. Photocopy of the duplicate of the business license;6. Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、审批机关的批准文件（批复和批准证书副本1）3、投资者名称变更的证明文件4、公司法定代表人签署的公司章程修正案或修改后的公司章程5、营业执照副本复印件6、其它有关文件The registration form for company form modification1. "The Modification (for record) Registration Application Form for Foreign Invested Enterprises" signed by the legal representative of the company;Invested Enterprises" signed by the legal representative of the company;2. Approval document issued by the approval authority (one duplicate of the official reply and the approval certificate);3. Resolution or decision made according to the law;4. The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5. Photocopy of the duplicate of the business license;6. Other relevant documents;1、公司法定代表人签署的《外商投资企业变更（备案）登记申请书》2、审批机关的批准文件（批复和批准证书副本1）3、依法作出的决议或决定4、公司法定代表人签署的公司章程修正案或修改后的公司章程5、营业执照副本复印件6、其它有关文件Increase branches1. "The modification (for record) registration application form for foreign invested enterprises";2. Resolution made according to the law;3. The approval document issued by the approval authority;4. Photocopy of the business license;5. Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、依法作出的决议3、审批机关的批准文件4、营业执照复印件5、其它有关文件Disband branches1. "The modification (for record) registration application form for foreign invested enterprises";2. Resolution or decision made according to the law;3. The approval document issued by the approval authority;4. The cancellation certificate issued by the registration authority of the branch (administrative office);5. Photocopy of the duplicate of the business license;6. Other relevant documents and certificates;1、《外商投资企业变更（备案）登记申请书》2、依法作出的决议或决定3、审批机关的批准文件4、分支（办事）机构登记机关出具的注销证明5、营业执照副本复印件6、其它有关文件、证件Put the director (supervisor) on record1. "The modification (for record) registration application form for foreign invested enterprises";2. The dismissal document of the former director, supervisor or manager and the appointment document and photocopy of identification paper of the new director, supervisor or manager;3. The dismissal documents of former members of the Joint ManagementCommittee and the appointment documents and photocopies of identification papers of new members of the Joint Management Committee;4. "Basic information of the director, supervisor or manager/members of the Joint Management Committee";5. Photocopy of the duplicate of the business license;6. Other relevant documents;1、《外商投资企业变更（备案）登记申请书》2、原董事、监事、经理的免职文件和新任董事、监事、经理的任职文件及身份证明复印件3、原联合管理委员会委员的免职文件和新任联合管理委员会委员的任职文件及身份证明复印件4、《董事、监事、经理/联合管理委员会委员情况表》5、营业执照副本复印件6、其它有关文件Put other items on record1. Stock equity hypothecation:A. "The modification (for record) registration application form for foreign invested enterprises";B. Approval document of the approval authority;C. Resolution or decision made according to the law;D. The legal hypothecation contract agreed by other investors;E. Photocopy of the duplicate of the business license;股权质押：a. 《外商投资企业变更（备案）登记申请书》b. 审批机关批准文件c. 依法做出的决议或决定d. 依法经其他投资方同意的质押合同e. 营业执照副本复印件2. Branch company:A. "The modification (for record) registration application form for foreign invested enterprises";B. Photocopy of the duplicate of the branch company's business license;C. Photocopy of the duplicate of the company's business license;D. Others分公司：a. 《外商投资企业变更（备案）登记申请书》b. 分公司营业执照副本的复印件c. 公司营业执照副本的复印件d. 其他材料3. Members or chief of the liquidation team:A. "The modification (for record) registration application form for foreign invested enterprises" signed by the chief of the company's liquidation team;B. Resolution or decision made according to the law;C. Photocopy of the duplicate of the business license;D. Others清算组成员清算组负责人：a. 公司清算组负责人签署的《外商投资企业变更（备案）登记申请书》b. 依法做出的决议或决定c. 营业执照副本复印件d. 其他材料4. Modification of the articles of association that does not relate to the registered items:A. "The modification (for record) registration application form for foreign invested enterprises";B. The approval document issued by the approval authority;C. The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;D. Photocopy of the duplicate of the business license;不涉及登记事项的章程修改：a.《外商投资企业变更（备案）登记申请书》b. 审批机关的批准文件c. 公司法定代表人签署的公司章程修正案或修改后的公司章程d. 营业执照副本复印件5. Overseas shareholder, founder or recipient of legal documents:A. "The modification (for record) registration application form for foreign invested enterprises";B. "Letter of attorney for the serving of legal documents";C. Photocopy of the proof of subject qualification of the authorized person;境外股东、发起人法律文件送达接受人：a. 《外商投资企业变更（备案）登记申请书》b. 《法律文件送达授权委托书》c. 被授权人的主体资格证明复印件6. Contact person for industrial and commercial registrationA. "The modification (for record) registration application form for foreign invested enterprises";B. Basic information of the contact person for industrial and commercial registration工商登记联络员：a. 《外商投资企业变更（备案）登记申请书》b. 工商登记联络员基本情况。
原料药新加坡的注册流程
原料药新加坡的注册流程1.原料药在新加坡注册需要先获得药品注册局的批准。
The registration of active pharmaceutical ingredients in Singapore requires approval from the Health Sciences Authority.2.首先需要提交注册申请表格和相关文件。
First, you need to submit the registration application form and relevant documents.3.文件需要包括质量控制及生产方法等资料。
The documents should include information on quality control and manufacturing methods.4.提交的文件需要经过严格的审查。
The submitted documents will undergo a rigorous review.5.如果文件符合要求，注册局将会发出批准函。
If the documents meet the requirements, the Health Sciences Authority will issue an approval letter.6.接下来，需要支付注册费用。
Next, you will need to pay the registration fees.7.注册局将进行实地考察生产工厂。
The registration authority will conduct on-site inspections of the manufacturing facility.8.考察结果将影响注册申请的进展。
The inspection results will affect the progress of the registration application.9.一旦注册获得批准，就可以开始在新加坡生产原料药。
药品注册英文
药品注册英文公司标准化编码 [QQX96QT-XQQB89Q8-NQQJ6Q8-MQM9N]Glossary（术语）：Regulatory Affairs （RA）：药政事务drug authority：药政当局investigation and research before project approval：立项前的调研Market Authorization （MA）：上市许可post-approval commitment study：上市后的承诺研究post-approval variation application：补充申请life cycle：生命周期Chemistry, Manufacturing, and Controls （CMC）：药品的化学、生产和控制cross-functional teams：公司内部各部门look at the big picture：从大局考虑think strategically：进行战略性思考risks and benefits：风险和获益Food and Drug Administration （FDA）：美国食品药品监督管理局European Medicines Agency （EMA）：欧洲药品管理局International Multi-center Clinical Trial （IMCT）：国际多中心临床试验Bioequivalence study （BE study）：生物等效性试验generic drug：仿制药Center for Drug Evaluation （CDE）：SFDA下属的药品审评中心Quality by Design （QbD）：质量源于设计CMC Pilot Program：FDA在业内开展的关于QbD的试点研究early launch：早日上市design space：设计空间Business Development （BD）：业务发展部门Imported Drug License （IDL）：进口药品注册证Manufacturing License （ML）：生产许可证Clinical Trial Permission （CTP）：临床试验批件Active Pharmaceutical Ingredient （API）：原料药Orange Book：橙皮书business value：商业价值the Pharmacopoeia of the People's Republic of China （ChP）：中国药典the United States Pharmacopoeia （USP）：美国药典the European Pharmacopoeia （Ph. Eur.或EP）：欧洲药典List of Essential Drugs （EDL）：基本药物目录Reimbursement Drug List （RDL）：医保目录）typing error：打印错误slip of the pen：笔误Drug Master File （DMF）：药物主文件Certificate of Analysis （CoA）：检验报告Marketing （MKT）：市场部market share：市场占有率sales volume：销量investigator brochure （IB）：研究者手册protocol：临床试验方案priority：优先度package insert （PI）：说明书labeling：包装标签Patient Information Leaflet （PIL）：患者使用的说明书Summary of Product Characteristics （SmPC，SPC）：产品特性摘要foil：铝箔carton：装药品的小盒shipping label：运输包装标签Medical：医学部provincial drug administration （PDA）：省级药监局，包括省、自治区和直辖市药品监督管理部门Institute for Food and Drug Control：药检所National Institute for the Control of Pharmaceutical and Biological Products （NICPBP）：中国药品生物制品检定所，简称“中检所”supplementary dossier：补充资料approval letter：注册批件out of specification （OOS）：超出标准、不合格adverse effect （AE）：不良事件trial waiver：减免临床试验Clinical：临床部门Commercial：商业部门new chemical entity （NCE）：新化学实体key opinion leader （KOL）：关键意见领袖off-label use：标签外使用patient pool：患者库deadline：最后期限global trial：全球性的临床试验，即国际多中心临床试验regional trial：区域性的临床试验TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics (PK ) 药物代谢动力学。
葡萄新品种登记与新品种权的申请流程
葡萄新品种登记与新品种权的申请流程张克坤1，樊秀彩1,2，王晨1，上官凌飞1，房经贵1*（1. 南京农业大学园艺学院/江苏省果树品种改良与种苗繁育工程中心，江苏南京 210095；2. 中国农业科学院郑州果树所，河南郑州 450009）Application process of new variety registration and new variety rightof grape in ChinaZhang Kekun 1, Fan Xiucai 1,2, Wang Chen 1, Shangguan Lingfei 1, Fang Jinggui 1*(1. College of horticulture, nanjing agricultural university/Fruit Tree Cultivar Improvement and SeedlingBreeding engineering Center of Jiangsu, nanjing 210095, China; 2. Zhengzhou Fruit Reseach Institute, Chinese academy of agricultural Sciences, Zhengzhou 450009, China)摘 要：新品种审定或登记是为了保证农业生产秩序而对新育成或新引进的品种即将进入生产环节时所采取的强制管理措施。
农作物新品种在进行生产推广前均要进行生产试验及区域试验，完成新品种的审定或登记过程。
新品种权属于知识产权范畴，是国家为鼓励植物新品种培育而赋予育种人或单位的排他使用权。
自2017年5月1日以来，我国开始实行《非主要农作物品种登记办法》，葡萄等非主要农作物的育种、繁育进入规范化管理的新阶段。
为使广大葡萄育种工作者更全面地了解葡萄新品种的登记过程以及新品种权申报流程，本文系统介绍了葡萄新品种登记、新品种权申请的流程及注意事项。
药品注册英文
Glossary术语：Regulatory Affairs RA：药政事务drug authority：药政当局investigation and research before project approval：立项前的调研Market Authorization MA：上市许可post-approval commitment study：上市后的承诺研究post-approval variation application：补充申请life cycle：生命周期Chemistry, Manufacturing, and Controls CMC：药品的化学、生产和控制cross-functional teams：公司内部各部门look at the big picture：从大局考虑think strategically：进行战略性思考risks and benefits：风险和获益Food and Drug Administration FDA：美国食品药品监督管理局European Medicines Agency EMA：欧洲药品管理局International Multi-center Clinical Trial IMCT：国际多中心临床试验Bioequivalence study BE study：生物等效性试验generic drug：仿制药Center for Drug Evaluation CDE：SFDA下属的药品审评中心Quality by Design QbD：质量源于设计CMC Pilot Program：FDA在业内开展的关于QbD的试点研究early launch：早日上市design space：设计空间Business Development BD：业务发展部门Imported Drug License IDL：进口药品注册证Manufacturing License ML：生产许可证Clinical Trial Permission CTP：临床试验批件Active Pharmaceutical Ingredient API：原料药Orange Book：橙皮书business value：商业价值the Pharmacopoeia of the People's Republic of ChinaChP：中国药典the United States Pharmacopoeia USP：美国药典the European Pharmacopoeia Ph. Eur.或EP：欧洲药典List of Essential Drugs EDL：基本药物目录Reimbursement Drug List RDL：医保目录typing error：打印错误slip of the pen：笔误Drug Master File DMF：药物主文件Certificate of Analysis CoA：检验报告Marketing MKT：市场部market share：市场占有率sales volume：销量investigator brochure IB：研究者手册protocol：临床试验方案priority：优先度package insert PI：说明书labeling：包装标签Patient Information Leaflet PIL：患者使用的说明书Summary of Product Characteristics SmPC,SPC：产品特性摘要foil：铝箔carton：装药品的小盒shipping label：运输包装标签Medical：医学部provincial drug administration PDA：省级药监局,包括省、自治区和直辖市药品监督管理部门Institute for Food and Drug Control：药检所National Institute for the Control of Pharmaceutical and Biological Products NICPBP：中国药品生物制品检定所,简称“中检所”supplementary dossier：补充资料approval letter：注册批件out of specification OOS：超出标准、不合格adverse effect AE：不良事件trial waiver：减免临床试验Clinical：临床部门Commercial：商业部门new chemical entity NCE：新化学实体key opinion leader KOL：关键意见领袖off-label use：标签外使用patient pool：患者库deadline：最后期限global trial：全球性的临床试验,即国际多中心临床试验regional trial：区域性的临床试验TPD 加拿大卫生部治疗产品局adverse drug reaction, ADR 药物不良反应pharmacokinetics PK 药物代谢动力学。
AGENDAOFTHEMEETINGOF-UNMStudent…会议的议程u2014..
The Board of Regents of the University of New MexicoMeeting in Open Session and Executive SessionMay 9, 2014, 10:30 AMStudent Union Building, Ballroom C / Executive Session-Luncheon in Cherry Silver Roomrevised AGENDA(only change is meeting start time changed by 30 min., from 10:00 am. to 10:30 am.)TABI. Call to Order, Confirmation of a Quorum and Adoption of the Agenda (1)Regent President Jack L. FortnerII. Approval of Minutes: March 25, 2014 Budget Summit, March 28 Budget meeting, April 8, 2014 Regular Meeting and April 14, 2014 Special Meeting (2)III. Comments from Advisors (3)Randy Royster, President UNM Alumni Association (report included in Agenda eBook)Gene Henley, President, UNM Staff CouncilRichard Holder, President, UNM Faculty Senate (letter included in Agenda eBook)Priscila Poliana, President, UNM GPSAIsaac Romero, President, ASUNMCarl Alongi, Chair, UNM Foundation Board of Trustees (will give report at June BOR)Angi Gonzales-Carver, President, UNM Parent AssociationDon Duszynski, President, UNM Retiree AssociationPublic Comment, specific to agenda items (limit 3 min. per speaker)IV. Fiscal Watch Report and Monthly Consolidated Financial Report (4)Liz Metzger, University ControllerV. The President’s Administrative Report, President Robert G. Frank (5)Recognition: Chief Kathy Guimond; Dr. Breda BovaUniversity Based Retirement Community Discussion (UBRC)Comments from RegentsVI. Budget Approval (6)1. Approval of FY2014/2015 UNM Consolidated Budgeta. Main Campus, Andrew Cullenb. Health Sciences, Ava Lovellc. Branch Campuses, Wynn Goeringd. UNM Consolidated, Andrew Cullen2. Approval of FY2013/2014 Budget Adjustment Request (BAR)Andrew Cullen, AVP Planning, Budget & Analysis; Ava Lovell, Senior Exec. Officer, Finance & Administration HSCVII. Regent Committee ReportsFinance and Facilities Committee, Regent James H. Koch, ChairConsent Items:1. Disposition of Surplus Property for Main Campus on list dated 4/18/2014 (7)Bruce Cherrin, Chief Procurement Officer2. Approval of Projects:a. Chemistry Building Renovations – Phase I (Clark Hall) (8)b. Taos Core Student Success Center (9)Chris Vallejos, AVP Institutional Support Services3. Approval of Reappointment and Appointment to STC Board (10)Lisa Kuuttila, Pres. & CEO STC.UNMAction Item:4. Discussion and Approval of UNM West, Facilities Plan (11)Wynn Goering, CEO UNM WestAcademic/Student Affairs & Research Committee, Student Regent Heidi Overton, Vice Chair5. Update from the Provost, Chaouki Abdallah (12)Action Item:6. Proposed AIMS Plan for UNM West (13)Wynn Goering, CEO UNM West, Special Assistant to the President for Branch Affairs; Kathy Sandoval, Dir.Albuquerque Institute for Mathematics and ScienceConsent Items:7. Approval of Form C: C1353-New AAS Environmental Technology – Los AlamosBranch (14)Dr. Cedric Page, Executive Dir. UNM Los Alamos; Dawn Venhaus, Dept. Chair of Science, Los Alamos Branch8. Approval of Form C: New-National Security and Strategic Analysis Certificate (15)Matthew R. Baca, Senior Program Manager, National Securities Studies Program9. Approval of Form D: Masters in Public Policy, Departments of Economics,Political Science and Sociology, and the School of Public Administration (16)Mark Peceny, Dean College of Arts and Sciences10. Approval of Form D: Graduate Certificate, Teaching English as a Second Language (17)Holbrook Mahn, Professor Language Literacy and Sociocultural11. GPSA Constitutional Amendments (18)a. Combine Executive and Legislative Finance Committeesb. Chief of Staff Positionc. Approval of 9 credit hours of tuition and fees to Council Chair and Chief of StaffPriscila Poliana, President Graduate and Professional Students AssociationAction Items:12. Spring 2014 Degree Candidates, Richard Holder, President Faculty Senate (19)Full list of degree candidates, including Health Sciences degree candidates (School of Medicine, College ofNursing, College of Pharmacy also receive approval from the Health Sciences Board of Directors)13. Approval of Faculty Senate Policy Revision C280-Leave without pay (20)Carol Parker, Senior Vice Provost for Academic AffairsInformation Items:14. First MOOC Experience at UNM (21)Greg Heileman, Associate Provost for Curriculum15. Redesign of New Student Orientation (22)Sonia Rankin, Assoc. Dean University CollegeHealth Sciences Board, Regent Suzanne Quillen, ChairAction Item: (candidates included in ASAR action item #12)1. Approval of Spring 2014 Degree Candidates (23)a. UNM College of Nursingb. UNM School of Medicinec. UNM College of PharmacyConsent Items:2. Approval of Resolution appointing Dr. Michael Richards to the UNM SandovalRegional Medical Center, Inc. Board of Directors (24)3. Approval of Resolution for the UNM Sandoval Regional Medical Center, Inc. Boardof Directors Second Amended and Restated Bylaws (25)4. Approval of Resolution for the UNM Medical Group, Inc. Board of Directors ThirdAmended and Restated Bylaws (26)5. Approval of Resolution for the Appointments to the UNM Medical Group, Inc. Boardof Directors (27)6. Approval of Resolution for the Appointment of Mr. Charlie Lopez to the UNM CarrieTingley Hospital Advisory Board (28)Action Items:7. Approval of the Fiscal Year 2014/2015 Budgets and (29)the Fiscal Year 2013/2014 Budget Adjustment Request (BAR) (30)Ava Lovell, Senior Exec. Officer, Finance & Administration HSC(see Agenda Item VI)8. Approval of the Resolution for Capital Project and Architect Approval for UNMHospitals, UNM Cancer Center Clinical Facility Build-Out (31)Ava Lovell, Senior Exec. Officer, Finance & Administration HSCInformation Items:9. HSC Financial Update and Update on Uncompensated Care (32)Ava Lovell, Senior Exec. Officer, Finance & Administration HSC10. Sandoval Regional Medical Center, Inc. Monthly Update (33)Steve McKernan, CEO UNM HospitalsAudit Committee, Regent Gene Gallegos, Chair– No Report(The next Audit Committee meeting will be on May 23, 2014.)VIII. Public Comment (items not on agenda; limit 3 min. per speaker)IX. Vote to close the meeting and proceed in Executive SessionExecutive Session-Cherry Silver Room1. Discussion and determination where appropriate of the purchase, acquisition ordisposal of real property pursuant to Section 10-15-1.H(8), NMSA (1978)2. Discussion and determination where appropriate of strategic and long-rangebusiness plans or trade secrets of public hospitals pursuant to Section 10-15-1.H(9), NMSA (1978)3. Discussion of personally identifiable information about any individual studentpursuant to Section 10-15-1.H(3), NMSA (1978)4. Discussion and determination where appropriate of threatened or pendinglitigation pursuant to Section 10-15-1.H(7), NMSA (1978)X. Vote to re-open the meeting and certification that only those matters described in Agenda Item IX. were discussed in Executive Session and if necessary, finalaction with regard to those matters will be taken in Open Session.XI. Vote to AdjournXII. Addendum: Minutes approved at the HSC Board of Directors 5/02/14 Meeting (34)a. HSC Board of Directors April 4, 2014 Meetingb. UNM Hospitals Board of Trustees March 28, 2014 Meetingc. Sandoval Regional Medical Center, Inc. Board of Directors March 26, 2014 Meeting。
国际药物注册英语词汇
国际药物注册英语词汇互译FDA（food and drug adminisration）：（美国）食品药品监督管理局NDA（new drug application）：新药申请ANDA（abbreviated new drug application）：简化新药申请EP（export application）：出口药申请（申请出口不被批准在美国销售的药品）treatment IND：研究中的新药用于治疗abbreviated（new）drug：简化申请的新药DMF（drug master file）：药物主文件（持有者为谨慎起见而准备的保密资料，可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、NDA、ANDA时才能参考其内容）holder：DMF持有者CFR（code of federal regulation）：（美国）联邦法规PANEL：专家小组batch production：批量生产；分批生产batch production records：生产批号记录post or pre-market surveillance：销售前或销售后监督informed consent：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）prescription drug：处方药OTC drug（over—the—counter drug）：非处方药U.S. public health service：美国卫生福利部NIH（national institute of health）：（美国）全国卫生研究所animal trail：动物试验accelerated approval：加速批准standard drug：标准药物investigator ：研究人员；调研人员preparing and submitting：起草和申报submission：申报；递交benefit(s)：受益risk（s）：受害drug product：药物产品drug substance：原料药established name：确定的名称generic name：非专利名称proprietary name：专有名称；INN（international nonproprietary name）：国际非专有名称narrative summary: 记叙体概要adverse effect：副作用adverse reaction：不良反应protocol：方案archival copy：存档用副本review copy：审查用副本official compendium：法定药典（主要指USP、NF）．USP（the united state pharmacopeia）：美国药典（现已和NF合并一起出版）NF（national formulary）：（美国）国家药品集official＝pharmacopeial = compendial：药典的；法定的；官方的agency：审理部门（指FDA）sponsor：主办者（指负责并着手临床研究者）identity：真伪；鉴别；特性strength：规格；规格含量（每一剂量单位所含有效成分的量）labeled amount：标示量regulatory specification：质量管理规格标准（NDA提供）regulatory methodology：质量管理方法（FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤）regulatory methods validation：管理用分析方法的验证（FDA对NDA 提供的方法进行验证）Dietary supplement：食用补充品ICH（International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICH：Quality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (SecondRevision)新原料药和制剂的稳定性试验（第二版）Q1B: Photostability Testing of New Drug Substances and Products 新原料药和制剂的光稳定性试验Q1C: Stability T esting for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of DrugSubstances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in ClimaticZones III and IV在气候带III和IV，药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证：方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质（修订版）Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质（修订版）Q3C: Impurities: Guideline for Residual Solvents杂质：残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance) 杂质：残留溶剂指南（修改内容）Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability 药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from CellLines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the ExpressionConstruct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing ofBiotechnological/Biological Products生物技术产品的质量：生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject toChanges in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New DrugSubstances and New Drug Products: Chemical Substances质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria forBiotechnological/Biological Products质量规格：生物技术/生物产品的检验程序和可接收标准Q7: Good Manufacturing Practices for Pharmaceutical Ingredients 活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for ActivePharmaceuticalIngredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH：Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录：极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests forPharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing forPharmaceuticals基因毒性：药物基因毒性检验的标准S3A: Note for Guidance on T oxicokinetics: The Assessment of SystemicExposure in T oxicity Studies毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue DistributionStudies药物代谢动力学：重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic T oxicity Testing in Animals (Rodent and Non-Rodent T oxicity Testing)动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）S5A: Detection of Toxicity to Reproduction for Medicinal Products 药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on T oxicity to Male Fertility:An Addendum to the Guideline on Detection of T oxicity to Reproduction forMedicinal Products对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed VentricularRepolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化（QT间期）潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies forthe Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy（有效）E1: The Extent of Population Exposure to Assess Clinical Safety for DrugsIntended for Long-Term Treatment of Non-Life-ThreateningConditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards forExpedited Reporting临床安全数据管理：速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety DataManagement Data Elements for Transmission of Individual Case SafetyReports个案安全报告送交的临床安全数据管理的数据要素指南（E2B（M））的修订版E2B (M): Maintenance of the Clinical Safety Data Management including:Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括：个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management includingQuestions and Answers临床安全数据管理的变动，包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports forMarketed Drugs临床安全数据管理：已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录：已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards forExpedited Reporting批准后的安全数据管理：速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量－效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP：良好的临床规范：统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究：老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the PediatricPopulation小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation andProarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information(ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status ofthe guidelines)通用技术文件（见有关CTD章节）M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP：time-to-progression 疾病进展时间SAE：severity Adverse Event 严重不良事件AE：Adverse Event 不良事件SOP：Standard Operating Procedure 标准操作规程CRF：Case Report form 病例报告表DLT：剂量限制毒性MTD：最大耐受剂量KPS：Karnofsky Performance Status行为状态评分CR：complete response完全缓解PR：partial response部分缓解SD：病情稳定PD：progressive disease病情进展CTC：常用药物毒性标准IEC：independent ethics committee 独立伦理委员会IRB ：institutional review board 伦理委员会CRA：临床研究助理CRO：Contract Research Organization 合同研究组织DFS：Disease Free Survival 无病生存期OS：（Overall Survival）总生存时间IC：Informed consent 知情同意ADR：Adverse Drug Reaction 不良反应GAP：Good Agricultural Practice 中药材种植管理规范GCP：Good Clinical Practice 药物临床试验质量管理规范GLP：Good Laboratory Practice 药品实验室管理规范GMP：Good Manufacturing Practice 药品生产质量管理规范GSP：Good Supply Practice 药品经营质量管理规范GUP：Good Use Practice 药品使用质量管理规范PI ：Principal investigator 主要研究者CI：Co-inveatigator 合作研究者SI ：Sub-investigator 助理研究者COI ：Coordinating investigtor 协调研究者DGMP：医疗器械生产质量管理规范ICF：Informed consent form 知情同意书RCT ：randomized controlled trial, 随机对照试验NRCCT：non-randomized concurrent controlled trial, 非随机同期对照试验EBM：evidence-based medicine 循证医学RCD：randomized cross-over disgn 随机交叉对照试验HCT：historial control trial, 历史对照研究RECIST：Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC：Quality Control质量控制UADR：Unexpected Adverse Drug Reaction，非预期药物不良反应。
分类别英语词汇
分类别英语词汇一. 起居类分类词汇1.卧室blanket 毛毯cushion 垫子quilt 被子cotton terry blanket 毛巾被 feather quilt 羽绒被 cotton quilt 棉被bedding 床上用品mosquito net 蚊帐pillow 枕头bolster 长枕pillow case 枕套tick 褥子carpet 地毯 (一般指大的整块的，铺房间的那种)rug 地毯(一般指小块的，放在沙发等边上的那种)bed frame/bed base 床架 headboard 床头板sofa bed 沙发床folding guest bed 折叠床 loftbed frame 架在空中的床(下面可放沙发、桌子等)bunkbed frame 上下铺的床 slatted bed base 板条床 sprung base 弹簧床bedspread 床罩sheet 床单mat 席子mattress 床垫 (厚的那种) mattress pad 床垫 (薄的那种) bed canopy 支在床上的篷子 (一般用于儿童床上的装饰)bedside table 床头柜2. 厨房refrigerator 冰箱automatic rice cooker 电饭锅 steamer 蒸锅oven 烤箱grill 烧烤架toaster 烤面包机egg beater 打蛋器ice crusher 刨冰机food processor 食品加工机 paper towel 纸巾apron 围裙tableware 餐具plate 盘子dish 碟子bowl 碗cupboard 碗橱dining table 餐桌larder 食品柜drop-leaf table 可以折叠边缘的桌子chopping board 案板 cutlery tray 装餐具的容器3. 卫生间bathroom 浴室，厕所 flushing system 冲水系统 flush toilet 抽水马桶flush pipe 冲水管foul drainage system 排污水系统drainage 排水道ventilation shaft/pipe 通风管道toilet seat 马桶坐圈 toilet lid 马桶盖squatting pot 蹲式马桶 urinal 小便池toilet paper/tissue 卫生纸 toilet brush 马桶刷4. 浴室bathtub 浴缸hand shower 手握式淋浴器 shower nozzle 喷头tap faucet 水龙头plastic curtain 防水浴帘 shower cap 浴帽bath slipper 洗澡用拖鞋 bath mat 防滑垫towel hanger/holder 毛巾架 towel ring 毛巾环bath towel 浴巾soap stand 肥皂盒comb 梳子soap 肥皂shampoo 洗发露conditioner 护发素dryer 吹风机razor 刮胡刀toothpaste 牙膏toothbrush 牙刷5. 桌椅tea table 茶几coffee table 咖啡台 smoking set 烟具ashtray 烟灰缸thermos bottle/vacuum bottle 热水瓶door knob 门把手safety door hook 安全门钩 corridor 走廊elevator 升降电梯escalator 滚梯rocking chair 摇椅hanging seat 吊椅swivel armchair 旋转扶椅 footstool 凳子chaise longue 躺椅folding chair 折叠椅6. 柜子,架子wardrobe 衣柜cloth rail 挂衣服的栏杆 hook 钩子wall shelf 装在墙上放东西的架子bracket 墙上突出之托架 magazine file 装杂志等的架子 shoe cabinet/storage 鞋柜 wall cabinet 壁橱hook rack 挂钩架TV bench 电视柜bookcase 书架braked castor 装在家具脚上方便推行的轮子(如:storage unit on castors)10-drawer chest 十个抽屉的储存柜7. 电器dish drainer 晾干餐具的容器(类似铁丝筐)table cloth 桌布laundry bag 洗衣袋pail 洗衣桶ironing board 烫衣板 steam and dry iron 蒸汽电熨斗 electric iron 电熨斗 laundry drier 烘干机 spin-drier 旋转式脱水机 washing machine 洗衣机radiator 暖气片electric fan 电扇stand fan 落地电扇oscillating fan 摇头电扇 bed light/bed lamp 床头灯 fluorescent lamp 日光灯 ceiling lamp/pendant lamp 吊灯 desk/table lamp 台灯 wall light 壁灯floor lamp 落地灯chandelier 枝状吊灯 flashlight/eletric torch 手电筒8.杂物。
获批一类新药英文报道
获批一类新药英文报道Title: Approval Granted for a New Class of Medication In a significant development for the pharmaceutical industry, a groundbreaking new class of medication has received approval from regulatory authorities. The authorization was granted following extensive clinicaltrials and thorough evaluation of the drug's safety and efficacy profiles.This cutting-edge medication, known as [drug name], represents a major breakthrough in the treatment of [specific medical condition]. It is the result of years of meticulous research and innovative scientific advancements, offering hope to millions of patients worldwide.The [drug name] functions by targeting a previously unexplored mechanism in the human body, providing a unique approach to disease management. By manipulating specific biological pathways, this medication has shown exceptional effectiveness in alleviating symptoms, improving patient outcomes, and potentially even halting the progression of the condition.During the clinical trials, [drug name] demonstrated remarkable results, outperforming existing treatmentoptions in terms of both efficacy and safety. Patients experienced significant improvements in [symptom relief], leading to an enhanced quality of life and reduced reliance on other medications or interventions.Moreover, the potential side effects associated with [drug name] were found to be minimal and generally well-tolerated by study participants. This is a testament to the meticulous research and development process undertaken to ensure the drug's safety and its favorable risk-benefit profile.The approval of this novel medication marks a significant milestone for patients and healthcare professionals alike. With its unique mode of action and superior clinical outcomes, [drug name] has the potential to revolutionize the treatment landscape for [specific medical condition]. Additionally, it may open doors for further exploration and innovation in the field of medicine, inspiring researchers to uncover new therapeutic targets and develop more effective drugs.While the approval of a new class of medication is undoubtedly cause for celebration, it is essential to remember that ongoing monitoring and post-marketing studieswill continue to assess the drug's long-term safety and effectiveness. Additionally, healthcare professionals will play a crucial role in ensuring appropriate patient selection, monitoring, and adherence to treatment guidelines to optimize the benefits of [drug name].The introduction of this new medication offers renewed hope for patients grappling with [specific medical condition]. As further research and clinical experience accumulate, the full potential of [drug name] is expected to unfold, promising a brighter future for individuals affected by this debilitating condition.。
approval在英语作文中的使用
approval在英语作文中的使用Approval is a critical concept in the English language and plays a significant role in various aspects of communication. The term "approval" refers to the act of officially or formally accepting or endorsing something or someone. It implies a positive evaluation or endorsement of an individual, action, or idea, and is often sought after in both personal and professional settings.In the realm of personal relationships, approval can be a powerful tool in building and maintaining strong bonds. When individuals feel that their actions, thoughts, or behaviors are approved of by those they care about, it can boost their self-confidence, self-esteem, and sense of belonging. This approval can come from family members, friends, or significant others, and can have a profound impact on an individual's overall well-being and emotional stability.In the professional sphere, approval is equally important. Employees often seek the approval of their superiors, colleagues, or clients to validate their work and demonstrate their competence. This approval can lead to promotions, increased responsibilities, and recognition within the organization. Conversely, the lack of approval can be detrimental to an individual's career progression and job satisfaction.Moreover, approval is integral to the decision-making process in various contexts. Governmental agencies, regulatory bodies, and other institutions often require the approval of specific authorities or stakeholders before implementing new policies, regulations, or projects. This approval process ensures that decisions are made with the appropriate level of scrutiny and consideration, ultimately serving the best interests of the community or organization.In the realm of education, approval plays a crucial role in the assessment and evaluation of students' academic performance. Teachers and professors often provide feedback and approval to students, recognizing their achievements, progress, and areas for improvement. This approval can motivate students to continue striving for excellence and can have a lasting impact on their academic and personal development.In the field of marketing and advertising, approval is a fundamental concept. Marketers often seek the approval of their target audience, ensuring that their products, services, or campaigns resonate with the intended consumers. This approval can be measured through various metrics, such as customer reviews, sales figures, and brand loyalty, and can ultimately determine the success or failure of a marketing strategy.Furthermore, approval is essential in the realm of scientific research and innovation. Researchers often seek the approval of their peers, academic institutions, and funding agencies to validate the significance and relevance of their work. This approval process ensures the quality and integrity of scientific research, and can lead to the advancement of knowledge and the development of groundbreaking discoveries.In conclusion, the concept of approval is a multifaceted and crucial aspect of the English language, permeating various aspects of our personal, professional, and societal lives. Whether it is the approval of loved ones, the endorsement of authority figures, or the recognition of one's achievements, the power of approval cannot be overstated. By understanding and embracing the role of approval in our lives, we can cultivate stronger relationships, achieve greater success, and contribute to the betterment of our communities and the world around us.。
校友会注册流程
校友会注册流程Joining an alumni association can be an exciting opportunity to reconnect with former classmates and teachers while also giving back to your alma mater. 校友会注册流程是一个非常具有挑战性和令人激动的过程，因为它可以让你重新连接并贡献自己的力量。
However, the registration process for some alumni associations can be quite complex and time-consuming, requiring potential members to fill out lengthy forms, provide detailed information about themselves, and pay a membership fee. 但是，对于某些校友会来说，注册流程可能会非常复杂和耗时，需要潜在成员填写冗长的表格，提供详细的个人信息，并支付会费。
One of the first steps in the registration process is to visit the alumni association's website and locate the registration page. 在注册流程中的第一步是访问校友会的网站并找到注册页面。
Once there, you will likely be asked to create an account by providing basic information such as your name, contact information, and graduation year. 一旦进入注册页面，你可能需要通过提供基本信息（如姓名、联系方式和毕业年份）来创建一个帐户。
用英语写打算举办班级聚会的作文
用英语写打算举办班级聚会的作文Organizing a Class Reunion.Reunions are a special occasion that bring people together after a period of separation, and class reunions are no exception. They are a chance for old classmates to catch up, reminisce about the past, and create new memories. As someone who values the importance of maintaining relationships and cherishing memories, I am excited to announce my intention to organize a class reunion.The first step in planning any event is to determinethe purpose and goals. In this case, the goal is to provide a platform for our classmates to reconnect, share stories, and relive the good old days. It is also an opportunity to introduce new members of our community, such as childrenand spouses, to the extended family of our alma mater.To ensure the success of the event, it is crucial to identify the target audience. In this instance, the targetaudience consists of our classmates, as well as any friends or family members who might be interested in attending. It is important to consider the age range and interests ofthis group to ensure that the activities and venue chosen are suitable for everyone.Choosing a venue is another crucial decision. It should be accessible to most people, provide ample space for mingling and activities, and have facilities to cater to any dietary restrictions or special needs. Additionally, the cost of the venue should be within the budget allocated for the event.The event itself should be structured in a way that allows for maximum interaction and engagement. This could include a mix of formal and informal activities, such as a welcome speech, group photos, a shared meal, and icebreaker games or trivia sessions. There could also be a designated time for open mic sessions, where people can share their stories or performances.To ensure maximum participation, it is important tocreate an effective promotion plan. This could includesocial media posts, emails, phone calls, and even word of mouth. Creating a Facebook event or a dedicated website can also help spread the word and keep everyone updated on the latest details.A key aspect of event planning is creating a budget. This should take into account all expenses, including the venue, catering, entertainment, printing costs forinvitations or name tags, and any other unexpected expenses. It is important to allocate a reasonable amount for each category and stick to the budget as much as possible.To ensure the smooth running of the event, it is essential to have a team of volunteers or helpers who can assist with various tasks such as setting up the venue, greeting guests, managing the registration desk, and ensuring that everything runs according to plan. Having a designated person responsible for each task can help keep things organized and prevent any last-minute chaos.Lastly, it is important to have a plan for follow-upafter the event. This could include sending thank-you emails or messages to everyone who attended, creating a shared album on social media for people to upload their photos, and even planning the next reunion.In conclusion, organizing a class reunion is a rewarding experience that can bring back memories and create new ones. It is an opportunity to reconnect with old friends and make new ones. With careful planning and preparation, it can be a successful and enjoyable eventthat everyone looks forward to attending.。
仿制药注册申报流程英文
仿制药注册申报流程英文Generic Drug Registration and Approval Process.The process of registering and approving generic drugs involves a meticulous and detailed journey, ensuring the safety, efficacy, and quality of the medication for public use. Here, we outline the general steps involved in the generic drug registration and approval process.1. Pre-Application Phase.Before submitting an application for generic drug registration, a thorough market research and analysis must be conducted. This involves identifying the need for the generic version of the drug, understanding the existing market size and competition, and assessing the potential market opportunities. Additionally, a review of the existing literature and patent status of the drug is crucial to ensure that the generic version does not infringe on any existing patents.2. Preparing the Application.Preparing the application for generic drug registration is a meticulous process. It involves compiling a comprehensive dossier that includes information on the active pharmaceutical ingredient (API), manufacturing process, quality control methods, stability data, preclinical and clinical trial data, and safety andefficacy data. The dossier must adhere to the regulatory requirements and guidelines set by the respective drug regulatory authority.3. Submitting the Application.After compiling the dossier, the next step is to submit the application to the drug regulatory authority. The application is typically submitted electronically through an online portal or via a designated submission route. The regulatory authority then reviews the application to ensure its completeness and compliance with the regulatory requirements.4. Technical Evaluation.Once the application is deemed complete, it enters the technical evaluation phase. This phase involves a detailed review of the dossier by experts from the drug regulatory authority. They assess the quality, safety, and efficacy data provided, evaluating the manufacturing process, API specifications, stability data, and clinical trial results. The reviewers may also request additional information or clarification from the applicant if needed.5. On-Site Inspection.During the technical evaluation phase, the drug regulatory authority may conduct an on-site inspection of the manufacturing facility. This inspection aims to ensure that the manufacturing processes, quality control methods, and facilities comply with the regulatory requirements. The inspectors assess the facilities, equipment, personnel, and documentation to verify the claims made in the dossier.6. Decision-Making.After completing the technical evaluation and on-site inspection, the drug regulatory authority makes a decision on the application. If the generic drug is approved, the authority grants a marketing authorization, allowing the applicant to sell the drug in the market. The decision is typically based on the evaluation of the dossier, on-site inspection results, and any additional information requested from the applicant.7. Post-Approval Monitoring.Once the generic drug is approved and marketed, the drug regulatory authority continues to monitor the safety and efficacy of the drug. This involves periodic safety updates, adverse event reporting, and compliance with post-market commitments made by the applicant. The authority may also conduct follow-up inspections to ensure continued compliance with regulatory requirements.In conclusion, the generic drug registration andapproval process is a comprehensive and rigorous journey. It ensures the safety, efficacy, and quality of generic drugs, protecting the public's health and safety. By adhering to the regulatory requirements and guidelines, generic drug manufacturers can ensure a smooth and successful registration and approval process.。
审批流程专业词语英文
审批流程专业词语英文English Answer：Approval Process Terminology.1. Approval Flow:Definition: A sequence of steps or stages through which a request for approval must pass before it can be granted.Types: Serial (sequential), Parallel (concurrent), Combinatorial (multiple paths)。
2. Approver:Definition: An individual or group with the authority to grant or deny approval based on pre-determined criteria.3. Approval Matrix:Definition: A visual representation that defines the approval levels and decision-making hierarchy within an organization.4. Approval Routing:Definition: The process of assigning approvers and determining the sequence in which they will review and approve a request.5. Approval Rules:Definition: Specific criteria or conditions that determine whether an approval request should be granted or denied.6. Conditional Approval:Definition: An approval granted subject to specific conditions or requirements that must be met before the request can be fully executed.7. Delegation of Approval:Definition: The transfer of approval authority from one individual or group to another.8. Electronic Approval System:Definition: A software tool that automates the approval process, streamlining the flow of approvals and reducing manual effort.9. Escalation:Definition: The process of moving an approval request to a higher level of authority if it is not approved within a certain time frame or meets specific criteria.10. Rejection:Definition: A denial of an approval request, typically accompanied by a reason or explanation.Chinese Answer：审批流程专业术语。
药品批准文号的注册流程
药品批准文号的注册流程英文回答：Registration Process for Drug Approval Numbers.The registration process for drug approval numbers varies depending on the regulatory authority in each country. However, there are some general steps that are common to most jurisdictions.1. Submission of an application: The first step is to submit an application to the regulatory authority. The application must include information about the drug, such as its name, composition, and intended use. It must also include data from clinical trials that demonstrate thedrug's safety and efficacy.2. Review of the application: The regulatory authority will review the application to determine whether it is complete and whether the drug meets the required safety andefficacy standards. The review process can take several months or even years.3. Approval of the drug: If the regulatory authority approves the drug, it will issue a drug approval number. This number is unique to each drug and is used to identify it in the marketplace.4. Marketing of the drug: Once the drug has been approved, it can be marketed to the public. The marketing must be in accordance with the terms of the drug approval.中文回答：药品批准文号的注册流程。
提倡毕业捐书的英语作文
提倡毕业捐书的英语作文Dear students,The ringing bell of parting is about to ring. After four years of struggle and hard work, you are about to bid farewell to the beautiful and familiar university campus and usher in another take-off in your life.Looking back on the calm, ordinary and colorful university life, you must have a lot of feelings and memories.Many alumni often recall the wonderful time they have spent in the library, searching for the true meaning of knowledge in the vast sea of books, and pondering the answers to the scientific problems under the quiet light.In recent years, many students have expressed a good wish to donate the books they have read to the library when they leave their Alma mater, so as to enrich the library collection and provide more good books to the younger students.We are very grateful to the students for their care and support for the library of our Alma mater. We also warmly welcome you to donate your good books, used teaching materials and teaching reference books to the library.The library will centralized registrationand management, and issue a donation certificate for your love, remember your selfless dedication.Donate a book, leave a true feelings.One book is not small, a hundred books are not much.We look forward to the students to donate books full of their deep love, so that the warm current of love in the elite campus forever!Perhaps a person's donation is limited, but the trickle, gathered into the sea, with your active participation, can converge into a sea of knowledge."Give people roses, leave lingering fragrance in your hand", your generous donation will benefit others, but also make the value of the book and your spiritual realm at the same time to get sublimation.Let the fragrance of books can convey friendship, and let the true feelings can last forever.Let you, let me, let us all act, fly love, embrace knowledge, share success.I wish the students in the future life journey on the journey, successful career!亲爱的同学们：离别的钟声即将敲响，在经历了四年的奋斗与拼搏之后，你们即将告别美丽熟悉的大学校园，迎来生命中的再一次腾飞。
电子厂职位的英文缩写及中文全称
电子厂里所有职位的英文缩写及中文全称品质人员名称类QC quality control 品质管理人员FQC final quality control 终点品质管制人员IPQC in process quality control 制程中的品质管制人员OQC output quality control 最终出货品质管制人员IQC incoming quality control 进料品质管制人员TQC total quality control 全面质量管理POC passage quality control 段检人员QA quality assurance 质量保证人员OQA output quality assurance 出货质量保证人员QE quality engineering 品质工程人员品质保证类FAI first article inspection 新品首件检查FAA first article assurance 首件确认CP capability index 能力指数CPK capability process index 模具制程能力参数SSQA standardized supplier quality audit 合格供应商品质评估FMEA failure model effectiveness analysis 失效模式分析FQC运作类AQL Acceptable Quality Level 运作类允收品质水准S/S Sample size 抽样检验样本大小ACC Accept 允收REE Reject 拒收CR Critical 极严重的MAJ Major 主要的MIN Minor 轻微的Q/R/S Quality/Reliability/Service 品质/可靠度/服务P/N Part Number 料号L/N Lot Number 批号AOD Accept On Deviation 特采UAI Use As It 特采FPIR First Piece Inspection Report 首件检查报告PPM Percent Per Million 百万分之一制程统计品管专类SPC Statistical Process Control 统计制程管制SQC Statistical Quality Control 统计品质管制GRR Gauge Reproductiveness & Repeatability 量具之再制性及重测性判断量可靠与否DIM Dimension 尺寸DIA Diameter 直径N Number 样品数其它品质术语类QIT Quality Improvement Team 品质改善小组ZD Zero Defect 零缺点QI Quality Improvement 品质改善QP Quality Policy 目标方针TQM Total Quality Management 全面品质管理RMA Return Material Audit 退料认可7QCTools 7 Quality Control Tools 品管七大手法通用之件类ECN Engineering Change Notice 工程变更通知(供应商)ECO Engineering Change Order 工程改动要求(客户)PCN Process Change Notice 工序改动通知PMP Product Management Plan 生产管制计划SIP Standard Inspection Procedure 制程检验标准程序SOP Standard Operation Procedure 制造作业规范IS Inspection Specification 成品检验规范BOM Bill Of Material 物料清单PS Package Specification 包装规范SPEC Specification 规格DWG Drawing 图面系统文件类ES Engineering Standard 工程标准CGOO China General PCE龙华厂文件IWS International Workman Standard 工艺标准ISO International Standard Organization 国际标准化组织GS General Specification 一般规格部类PMC Production & Material Control 生产和物料控制PCC Product control center 生产管制中心PPC Production Plan Control 生产计划控制MC Material Control 物料控制DC Document Center 资料中心QE Quality Engineering 品质工程(部)QA Quality Assurance 品质保证(处)QC Quality Control 品质管制(课)PD Product Department 生产部LAB Laboratory 实验室IE Industrial Engineering 工业工程R&D Research & Design 设计开发部生产类PCs Pieces 个(根,块等)PRS Pairs 双(对等)CTN Carton 卡通箱PAL Pallet/skid 栈板PO Purchasing Order 采购订单MO Manufacture Order 生产单D/C Date Code 生产日期码ID/C Identification Code (供应商)识别码SWR Special Work Request 特殊工作需求L/N Lot Number 批号P/N Part Number 料号OEM Original Equipment Manufacture 原设备制造PC Personal Computer 个人电脑CPU Central Processing Unit 中央处理器A.S.A.P As Soon As Possible 尽可能快的E-MAIL Electrical-Mail 电子邮件N/A Not Applicable 不适用QTY Quantity 数量I/O input/output 输入/输出NG Not Good 不行,不合格C=0 Critical=0 极严重不允许APP Approve 核准,认可,承认CHK Check 确认ASS'Y Assembly 装配,组装T/P True Position 真位度5WIH When, Where, Who, What, Why, How to6M Man, Machine, Material, Method, Measurement, Message4MTH Man, Material, Money, Method, Time, How 人力,物力,财务,技术,时间(资源)SQA Strategy Quality Assurance 策略品质保证DQA Design Quality Assurance 设计品质保证MQA Manufacture Quality Assurance 制造品质保证SSQA Sales and service Quality Assurance 销售及服务品质保证LRR Lot Reject Rate 批退率SPS Switching power supply 电源箱DT Desk Top 卧式(机箱)MT Mini-Tower 立式(机箱)DVD Digital Video DiskVCD Video Compact DiskLCD Liquid Crystal DisplayCAD Computer Aided DesignCAM Computer Aided ManufacturingCAE Computer Aided EngineeringPCB Printed Circuit Board 印刷电路板CAR Correction Action Report 改善报告NG Not Good 不良WDR Weekly Delivery Requirement 周出货要求PPM Percent Per Million 百万分之一TPM Total Production Maintenance 全面生产保养MRP Material Requirement Planning 物料需计划OS Operation System 作业系统TBA To Be Assured 待定,定缺D/C Drawing ChangeP/P Plans & ProcedureEMI Electrical-Music Industry 电子音乐工业Electrical Magnetic Interference 电子干扰RFI Read Frequency Input 读频输入MMC Maximum Material ConditionMMS Maximum Material SizeLMC Least Material ConditionLMS Least Material SizeLED lighting-emitting diode 发光二极管QBR Quarter Business RecordCIP Continuous improvement processFGI Forecasted Goal InventoryCNC Computerized numeral controllerB2C Business to customerB2B Business to businessAVL Approved vendor listPOP Procedure of packagingEOL End of lifeVDCS Vender defect correcting sheetPDCS Process defect correcting sheetGRN Goods receiving noteA/R Accounting receivableA/P Accounting payable通用类president董事长operator作业员position职务general manager总经理special assistant 特助deputy manager |'depjuti| =vice manager副理deputy supervisor =vice supervisor副课长group leader组长line leader线长supervisor 课长responsible department负责单位Human Resources Department人力资源部Head count 人头数production department生产部门planning department企划部QC Section品管课stamping factory冲压厂painting factory烤漆厂molding factory成型厂administration/general affairs dept./总务部production unit生产单位meeting minutes会议记录distribution department分发单位subject主题conclusion结论decision items决议事项pre-fixed finishing date预定完成日Color management 颜色管理Visual management 目视管理production capacity生产力first count初盘first check初盘复棹second count 复盘second check复盘复核quantity of physical inventory second count 复盘点数量physical inventory盘点数量physical count quantity帐面数量difference quantity差异量spare parts physical inventory list备品盘点清单cause analysis原因分析waste materials废料description品名specification 规格model机种work order工令revision版次remark备注registration登记registration card登记卡to control管制application form for purchase请购单consume, consumption消耗to notify通知to fill in填写to collect, to gather收集statistics统计cosmetic inspection standard 外观检验规范computer case 电脑外壳(组件)personal computer enclosure 电脑机箱产品front plate前板rear plate后板chassis |'∫æsi| 基座bezel panel面板Hood 上盖base pan 基座bezel 面板riser card 扩充卡flat cable 排线TOP driver cage 上磁架bottom driver cage 下磁架resin film 树脂膜raw materials原料materials物料steel plate钢板roll/coil material卷料spare parts =buffer备品plastic parts塑胶件sheet metal parts/stamping parts 冲件material check list物料检查表finished product成品semi-finished product半成品good product/accepted goods/。
邀请毕业生回母校参加校庆邀请函英语作文
邀请毕业生回母校参加校庆邀请函英语作文Dear Graduates,It is with great pleasure and excitement that I extend this invitation to you, our esteemed alumni, to join us in celebrating the [School Name] Annual Homecoming and Alumni Reunion. As we commemorate the [X] anniversary of our beloved institution, we cordially invite you to be a part of this momentous occasion and reconnect with your alma mater.The [School Name] has been a cornerstone of our community for decades, shaping the lives of countless individuals and preparing them for success in the ever-evolving world. As graduates, you have played a vital role in the growth and development of this institution, and it is with immense pride that we welcome you back to campus.This year's Homecoming and Alumni Reunion promises to be a truly remarkable event, filled with nostalgic memories, engaging activities, and the opportunity to reconnect with old friends and classmates. From [Date] to [Date], we have curated a schedule of events that will cater to the diverse interests and preferences of our alumni.One of the highlights of the celebration will be the [Event Name], where you will have the chance to reminisce about your time at [School Name] and share your experiences with fellow graduates. This event will feature a panel discussion with esteemed faculty members, who will provide insights into the latest advancements and initiatives within the school. Additionally, you will have the opportunity to participate in interactive workshops and networking sessions, allowing you to stay connected with the vibrant community that you once called home.Another exciting aspect of the reunion is the [Event Name], where you will have the chance to explore the campus and witness the remarkable transformations that have taken place since your graduation. From state-of-the-art facilities to innovative academic programs, the [School Name] has continued to evolve, ensuring that it remains at the forefront of educational excellence.We also invite you to join us for the [Event Name], where you can immerse yourself in the rich cultural heritage and traditions of our institution. This event will feature performances by talented student groups, showcasing the diverse talents and passions that thrive within our campus.Furthermore, we are thrilled to announce the [Event Name], a special gala dinner where you will have the opportunity to reconnect withyour former professors, administrators, and fellow alumni. This event will be a perfect occasion to celebrate the achievements of our community and honor the individuals who have made significant contributions to the [School Name] legacy.We understand that many of you may have established successful careers and have commitments that may make it challenging to attend the reunion. However, we encourage you to make every effort to join us, as your presence will undoubtedly enrich the experience for all attendees. Your participation will not only rekindle your connection with the [School Name] but also inspire current and future generations of students to follow in your footsteps.To ensure a seamless and memorable experience, we have provided detailed information about the various events, accommodations, and registration procedures on our dedicated Homecoming and Alumni Reunion website. We kindly request that you visit the website and complete the registration process at your earliest convenience.The [School Name] community eagerly awaits your return, and we look forward to welcoming you with open arms. This reunion is an opportunity to celebrate the enduring spirit of our institution and the lasting impact that our graduates have made on the world.We sincerely hope that you will join us in this momentouscelebration and contribute to the continued success and legacy of the [School Name].Warmest regards,[Your Name][Title][School Name]。
大型赛会志愿者礼宾部常用英语
礼宾部常用英语用语1、Is this everything，sir？这是全部东西吗，先生？2、Here's the light switch．这是电灯开关。
3、Here's the closet and there's the bathroom．这儿是壁柜。
这儿是洗澡间。
4、It's very kind of you to do so．你这样做使我很感激。
5、And by the way，could I have a look at your room card？顺便问一句，我可以看一下您的房卡吗？6、How do you like this room？您觉得这个房间怎么样？7、It's also quite spacious．房间也很宽敞。
8、Please sign your name here．请您在这里签名。
9、By the way，I'd like to tell you that the check-out time is 12∶00 noon，sir．先生，顺便告诉您，结账后离开旅馆时间是12点。
10、Have you used any hotel services this morning or had breakfast atthe hotel dining room，Mr.．Green？格林先生，今天早晨您是否用过旅馆服务设施，或在旅馆餐厅用过早餐？11、At what time would you like us to call you tomorrow morning？您想让我们明天早上什么时候叫醒您？12、That means that I'll have to be on the road by 7 o'clock at the latest．就是说我明天早晨最迟也要7点钟上路。
13、Will you pay by credit card？您准备用信用卡支付吗？14、No, if there is, I’ll it to you in time.没有。