Openational Amplifiers and Applications

TEST BANKCHAPTER 4: ORGANIZATIONAL AND MANGERIAL ISSUES IN LOGISTICS Multiple Choice Questions (correct answers are bolded)1. ___________ and ___________ are the two basic organizational structures associated with logistics.a. Centralized; hierarchicalb. Fragmented; centralizedc. Fragmented; unifiedd. Unified; hierarchical[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]2. In a ___________ logistics structure, logistics activities are managed in multiple departments throughout an organization.a. unifiedb. fragmentedc. decentralizedd. matrix[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]3. One problem with a ___________ logistics structure is that because logistics activities are scattered throughout a firm, they likely remain subservient to the objectives of the department in which they are housed.a. fragmentedb. matrixc. decentralizedd. hierarchical[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]4. In a ___________ logistics structure, multiple logistics activities are combined into, and managed as, a single department.a. hierarchicalb. centralizedc. matrixd. unified[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]5. A ___________ logistics organization implies that the corporation maintains a single logistics department that administers the related activities for the entire company from the home office.a. centralizedb. hierarchicalc. unifiedd. command-and-control[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]6. A(n) ___________ logistics organization means that logistics-related decisions are made separately at the divisional or product group level.a. fragmentedb. decentralizedc. flexibled. agile[LO 4.1: To explain organizational structure for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]7. A primary advantage of ___________ logistics is its relative efficiency, whereas a primary advantage of ___________ logistics is its customer responsiveness.a. unified; fragmentedb. unified; decentralizedc. centralized; decentralizedd. fragmented; centralized[LO 4.1: To explain organizational structure for logistics; Difficult; Synthesis; AACSB Category 3: Analytical thinking]8. Which of the following is an advantage of a decentralized logistics organization?a. It can be less expensive than a centralized organization.b. There are good opportunities for freight consolidation.c. There is better control over company data.d. It can be responsive to customer service requirements.[LO 4.1: To explain organizational structure for logistics; Difficult; Synthesis; AACSB Category 3: Analytical thinking]9. Which of the following is an advantage of a centralized logistics organization?a. It can be less expensive than a decentralized organization.b. It has good opportunities for freight consolidation.c. It can be responsive to customer service requirements.d. It is easier to manage than a decentralized organization.[LO 4.1: To explain organizational structure for logistics; Difficult; Synthesis; AACSB Category 3: Analytical thinking]10. ___________ organizational design has its foundations in the command-and-control military operation, where decision making and communication often follow a top-down flow.a. Centralizedb. Unifiedc. Matrixd. Hierarchical[LO 4.2: To compare traditional and contemporary organizational design for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]11. A ___________ organizational design attempts to create an organization that is responsive to the parameters of the contemporary business environment.a. matrixb. networkc. decentralizedd. unified[LO 4.2: To compare traditional and contemporary organizational design for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]12. A key attribute of network organizational design is a shift from ___________ to___________.a. function; processb. centralization; decentralizationc. process; functiond. decentralization; centralization[LO 4.2: To compare traditional and contemporary organizational design for logistics; Moderate; Application; AACSB Category 3: Analytical thinking]13. ___________ refers to satisfying current and emerging customer needs.a. Responsivenessb. Flexibilityc. Relevancyd. Accommodation[LO 4.2: To compare traditional and contemporary organizational design for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]14. ___________ can be defined as an organization’s ability to address unexpected operational situations.a. Relevancyb. Flexibilityc. Accommodationd. Responsiveness[LO 4.2: To compare traditional and contemporary organizational design for logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]15. ___________ refers to the amount of output divided by the amount of input.a. Controlb. Monitoringc. Productivityd. Input–output analysis[LO 4.3: To identify productivity issues and improvement efforts in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]16. Productivity improvement efforts in logistics are often directed toward ___________.a. reducing input while increasing outputb. increasing output by a greater percentage than inputs are increasedc. reducing input while holding output constantd. increasing output while holding input constant[LO 4.3: To identify productivity issues and improvement efforts in logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]17. What is the most important purpose of warehouse work rules?a. to control pilferageb. to keep employees from engaging in unproductive and potentially destructive activitiesc. to protect companies from union grievance proceduresd. to give managers control over warehouse workers[LO 4.3: To identify productivity issues and improvement efforts in logistics; Difficult; Synthesis; AACSB Category 3: Analytical thinking]18. What major retailer has been testing drones within its warehouses as a potential solution to enhance productivity?a. Amazonb. Home Depotc. Walmartd. Target[LO 4.3: To identify productivity issues and improvement efforts in logistics; Moderate; Application; AACSB Category 3: Analytical thinking]19. A ___________ is a device used to monitor and control the actions taken by a driver and his/her vehicle.a. tachographb. tachometerc. speedometerd. regulator[LO 4.3: To identify productivity issues and improvement efforts in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]20. ___________ refers to an organization making their unused resources available to other organizations.a. Sharing economyb. Flexibilityc. Responsivenessd. Excess capacity[LO 4.3: To identify productivity issues and improvement efforts in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]21. ___________ is a set of generic standards used to document, implement, and demonstrate quality management and assurance systems.a. Benchmarkingb. Six Sigmac. ISO 9000d. ISO 14000[LO 4.4: To discuss quality issues in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]22. The quality concept that emphasizes the elimination of business errors is known as___________.a. the Lean approachb. Six Sigmac. benchmarkingd. zero tolerance[LO 4.4: To discuss quality issues in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]23. ___________ refers to the integration of Six Sigma and the Lean approach.a. ISO 9000b. Quality managementc. Supply chain managementd. Lean Six Sigma[LO 4.4: To discuss quality issues in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]24. What is a key difference between IS0 9000 and the Malcolm Baldrige National Quality Award?a. Only the Baldrige Award focuses on quality.b. The Baldrige Award is more externally focused than is ISO 9000.c. ISO 9000 is more externally focused than the Baldrige Award.d. ISO 9000 focuses more on lean practices than does the Baldrige Award.[LO 4.4: To discuss quality issues in logistics; Difficult; Synthesis; AACSB Category 3: Analytical thinking]25. The ___________ has been established to identify uncertainty sources that can affect the risk exposure for logistics activities.a. Perfect Orderb. Logistics Uncertainty Pyramid Modelc. Department of Homeland Securityd. Logistics Risk Factor[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Concept; AACSB Category 3: Analytical thinking]26. From a logistics perspective, two of most important government agencies incorporated into the Department of Homeland Security (DHS) were the Transportation Security Administration (TSA) and ___________.a. Department of Transportationb. Federal Maritime Commissionc. Surface Transportation Boardd. Customs and Border Protection (CBP)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Difficult; Application; AACSB Category 3: Analytical thinking]27. The ___________ is responsible for the security of the U.S. transportation system.a. Department of Commerceb. Department of Transportationc. Transportation Security Administration (TSA)d. U.S. State Department[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]28. ___________ refers to a program where public and private organizations work together to prevent terrorism against the United States.a. Container Security Initiative (CSI)b. Importer Security Filing (ISF) rulec. Customs Trade Partnership Against Terrorism (C-TPAT)d. Securing America’s Borders (SAB)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]29. The Importer Security Filing (ISF) rule requires importers to file ___________ pieces of information and carriers to file ___________ pieces of information.a. 10; 2b. 5; 5c. 2; 10d. 4; 8[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]30. Which of the following statements is false?a. Pilferage refers to employee theft.b. T he time and costs associated with theft aren’t always covered by insurance.c. Some organizations avoid locating their facilities in areas characterized by high crime rates.d. Theft refers to stolen merchandise worth more than $500.[LO 4.6: To describe ways to manage theft and pilferage; Difficult; Synthesis; AACSB Category 3: Analytical thinking]31. The materials stolen in ___________ are usually for the employee’s own use.a. theftb. demurragec. non-monetary compensationd. pilferage[LO 4.6: To describe ways to manage theft and pilferage; Moderate; Concept; AACSB Category 3: Analytical thinking]32. What is the primary difference between pilferage and theft?a. There is no difference between the two terms.b. P ilferage involves a firm’s own employees, while theft involves efforts from outsiders.c. Theft refers to stolen merchandise worth more than $500.d. Pilferage refers to stolen merchandise worth more than $500.[LO 4.6: To describe ways to manage theft and pilferage; Difficult; Synthesis; AACSB Category 3: Analytical thinking]33. Approximately ___________ percent of all pirate attacks in recent years have involved petroleum tankers.a. 40b. 30c. 20d. 10[LO 4.6: To describe ways to manage theft and pilferage; Moderate; Application; AACSB Category 3: Analytical thinking]34 The concept of logistics social responsibility, or corporate social responsibility issues that relate directly to logistics, did not emerge until which decade?a. 1970sb. 1980sc. 1990sd. 2000s[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]35. The two areas in logistics systems where most energy costs occur are ___________ and___________.a. warehousing; transportationb. packaging; transportationc. materials handling; packagingd. warehousing; materials handling[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]36. With respect to the design of warehouses, one suggestion for energy savings is to make sure that dock doors are not placed on the ___________ side of a building.a. westb. eastc. northd. south[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]37. Transportation accounts for approximately ___________ of all petroleum consumption in the United States.a. three-quartersb. two-thirdsc. one-halfd. one-third[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]38. Which of the following is not one of the three critical factors associated with the process of managing returned goods?a. why products are returnedb. whether returned goods should be managed internally or outsourced to a third partyc. how to optimize reverse logisticsd. how many products are returned[LO 4.7: To review the concept of logistics social responsibility; Difficult; Synthesis; AACSB Category 3: Analytical thinking]39. ___________ complexity refers to the growing number nodes and the associated changes to the links in the logistics system.a. Processb. Rangec. Networkd. System[LO 4.8: To articulate logistics issues associated with complexity; Moderate; Concept; AACSB Category 3: Analytical thinking]40. ___________ complexity centers on the implications associated with the increasing number of products that most companies continue to face in an effort to differentiate themselves with their customers.a. Processb. Rangec. Networkd. System[LO 4.8: To articulate logistics issues associated with complexity; Moderate; Concept; AACSB Category 3: Analytical thinking]True-False Questions1.The organization of logistics activities within a firm depends on a number of factors,including the number and location of c ustomers and an organization’s size. (True)[LO 4.1: To explain organizational structure for logistics; Moderate; Application; AACSB Category 3: Analytical thinking]2.In a decentralized logistics structure, logistics activities are managed in multiple departmentsthroughout an organization. (False)[LO 4.1: To explain organizational structure for logistics; Easy; Concept; AACSB Category 3: Analytical thinking]3.One problem with a fragmented logistics structure is that because logistics activities arescattered throughout the firm, they likely remain subservient to the objectives of thedepartments in which they are housed. (True)[LO 4.1: To explain organizational structure for logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]4.In a unified logistics structure, multiple logistics activities are combined into, and managedas, a single department. (True)[LO 4.1: To explain organizational structure for logistics; Easy; Concept; AACSB Category 3: Analytical thinking]5. A centralized logistics organization generally results in better customer responsiveness than adecentralized logistics organization. (False)[LO 4.1: To explain organizational structure for logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]6. A decentralized logistics organization means that logistics-related decisions are made at thedivisional or product group level and often in different geographic areas. (True)[LO 4.1: To explain organizational structure for logistics; Easy; Concept; AACSB Category 3: Analytical thinking]7.The majority of companies employ a chief logistics officer (CLO). (False)[LO 4.1: To explain organizational structure for logistics; Moderate; Application; AACSB Category 3: Analytical thinking]8. A matrix organizational design can be very responsive to customer requirements. (True) [LO 4.2: Organizational design for logistics; Moderate; Application; AACSB Category 3: Analytical thinking]9.From a logistics perspective, a network organizational design in logistics is manifested interms of relevancy, responsiveness, and flexibility. (True)[LO 4.2: Organizational design for logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]10.Responsiveness refers to satisfying current and emerging customer needs. (False)[LO 4.2: Organizational design for logistics; Easy; Concept; AACSB Category 3: Analytical thinking]11.The postponement of product assembly and labeling until exact customer requirements areknown is an example of responsiveness. (False)[LO 4.2: Organizational design for logistics; Moderate; Application; AACSB Category 3: Analytical thinking]12.Productivity efforts in logistics are often directed at increasing the amount of output whileholding input constant. (True)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]13.Union work rules are often very specific in the sense that job descriptions spell out theresponsibilities associated with a particular job. (True)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Easy; Application; AACSB Category 3: Analytical thinking]14.Walmart has begun testing drones within its warehouses as a potential solution to enhancewarehouse productivity. (True)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Easy; Application; AACSB Category 3: Analytical thinking]15.The odometer is a recording instrument that produces a continuous, timed record of the truck,its speed, and its engine speed. (False)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]16.Wireless communications, global positioning systems, and graphical information systemsoffer tremendous opportunities to improve driver productivity. (True)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Moderate; Synthesis; AACSB Category 3: Analytical thinking]17.Excess capacity, or unused available space, can be unproductive because it may result in thepurchase of additional equipment or space. (True)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Moderate; Application; AACSB Category 3: Analytical thinking]18.Coopetition is a concept that entails an organization making its unused resources available toother organizations. (False)[LO 4.3 To identify productivity issues and improvement efforts in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]19.Logistics service quality relates to a firm’s ability to deliver products, materials, and serviceswithout defects or errors to both internal and external customers. (True)[LO 4.4 To discuss quality issues in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]20.ISO 14000 is a set of generic standards used to document, implement, and demonstratequality management and assurance systems. (False)[LO 4.4 To discuss quality issues in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]21.The integration of Six Sigma with the Lean approach refers to Lean Six Sigma. (True)[LO 4.4 To discuss quality issues in logistics; Easy; Concept; AACSB Category 3: Analytical thinking]22.ISO 9000 involves organizations benchmarking themselves against organizations fromoutside their particular industry. (False)[LO 4.4 To discuss quality issues in logistics; Moderate; Concept; AACSB Category 3: Analytical thinking]23.The Logistics Uncertainty Index has been established to identify uncertainty sources that canaffect the risk exposure for logistics activities. (False)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Concept; AACSB Category 3: Analytical thinking]24.Terrorism can be viewed as an illegal use of or threat of force or violence made by a group oran individual against a person, a company, or somebody’s property with a goal of menacing the target, often grounded in politics or ideology. (True)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Concept; AACSB Category 3: Analytical thinking]25.From a logistical perspective, the Transportation Security Administration (TSA) and theDepartment of Transportation are two of the most important government entities that were incorporated into the Department of Homeland Security (DHS). (False)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Synthesis; AACSB Category 3: Analytical thinking]26.The Transportation Worker Identification Credential (TWIC) uses biometric data to excludecertain workers from secure areas at ports and terminals. (True)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]27.Customs and Border Protection (CBP) is responsible for securing U.S. borders to protect theAmerican people and the U.S. economy. (True)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]panies that participate in the Customs Trade Partnership Against Terrorism (C-TPAT)are exempt from all import tariffs and all import quotas. (False)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Application; AACSB Category 3: Analytical thinking]29.The Importer Security Filing (ISF) rule requires carriers to file 10 pieces of information andimporters to file 2 pieces of information. (False)[LO 4.5: To report on programs designed to lessen the impact of terrorism on logistics systems; Moderate; Concept; AACSB Category 3: Analytical thinking]30.Experts recommend that the best pilferage policy should be based on zero tolerance. (True) [LO 4.6: To describe ways to manage theft and pilferage; Easy; Application; AACSB Category 3: Analytical thinking]31.One of the most effective methods of protecting goods from theft or pilferage is to keep themmoving through the system. (True)[LO 4.6: To describe ways to manage theft and pilferage; Moderate; Application; AACSB Category 3: Analytical thinking]32.More than 50 percent of all pirate attacks in recent years have involved petroleum tankers.(True)[LO 4.6: To describe ways to manage theft and pilferage; Moderate; Application; AACSB Category 3: Analytical thinking]33.Logistics does not have an inherent connection to sustainability. (False)[LO 4.7: To review the concept of logistics social responsibility; Easy; Application; AACSB Category 3: Analytical thinking]34.Potential logistics social responsibility dimensions include the environment, diversity, safety,and philanthropy, among others. (True)[LO 4.7: To review the concept of logistics social responsibility; Moderate; Synthesis; AACSB Category 3: Analytical thinking]35.Warehousing and packaging are the two areas in logistics systems where the most energycosts occur. (False)[LO 4.7: To review the concept of logistics social responsibility; Moderate; Synthesis; AACSB Category 3: Analytical thinking]36.Roof color is often overlooked as an area for warehousing energy control. (True)[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]37.Transportation accounts for about one-half of all petroleum consumption in the UnitedStates. (False)[LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]38.Reverse logistics can be four to five times more expensive than forward logistics. (True) [LO 4.7: To review the concept of logistics social responsibility; Moderate; Application; AACSB Category 3: Analytical thinking]work complexity refers to the growing number of nodes and the associated changes to thelinks in logistics systems. (True)[LO 4.8: To articulate logistics issues associated with complexity; Easy; Concept; AACSB Category 3: Analytical thinking]40.System complexity centers on the implications associated with the increasing number ofproducts that most companies continue to face in an effort to differentiate themselves with their customers. (False)[LO 4.8: To articulate logistics issues associated with complexity; Moderate; Concept; AACSB Category 3: Analytical thinking]。

英文回答：The licensing of endangered species in Western Ocean cucumber countries is an important policy initiative for environmental protection and sustainable development and requires strict approval and regulation。

The applicant should have a thorough knowledge of the relevant laws and regulations before processing the permit and ensure that the application is in accordance with the requirements。

The applicant is required toplete the application form and submit relevant supporting documentation， such as a certificate of origin of the Western cucumber， or a certificate of training in planting or breeding。

The applicant is required to pay the costs of the application and the potential environmental impact assessment。

Once the application materials and fees are submitted， the relevant authorities will conduct a rigorous review and assessment to determine whether the applicant meets the conditions for obtaining a licence。

一文读懂｜口罩等防疫用品出口欧盟及美国市场认证信息指南随着全球新冠肺炎疫情的不断蔓延和升级，各国政府和社会机构纷纷采取积极的防疫措施，其中最核心的就是防疫用品，比如口罩、防护服、护目镜等。

这些防疫用品的生产和出口也成为了全球关注的焦点。

为了让企业更好地了解市场认证信息和出口要求，本文将提供欧盟和美国市场口罩等防疫用品的认证信息指南。

一、欧盟市场认证信息指南欧盟市场被认为是世界上最严格的市场之一，在进口欧盟市场的口罩等防疫用品必须符合欧盟的标准和法规要求。

根据欧洲标准EN 149：2001+A1：2009，口罩的认证可以分为FFP1、FFP2和FFP3三个等级。

FFP1口罩的最小过滤效果是80%，FFP2口罩的最小过滤效果是94%，FFP3口罩的最小过滤效果是99%。

口罩的认证标准有欧洲联合CEN 所制定的标准和欧盟颁布的指令（Directive）。

欧洲联合CEN所制定的标准主要包括：1. EN 149：2001+A1：2009 呼吸器标准。

该标准规定了一系列保护级别（FFP1、FFP2和FFP3），以及最小过滤效果和最大呼吸阻力。

2. EN 14683：2019+AC:2019 手术口罩标准。

该标准规定了手术口罩的分类、性能要求、试验方法和包装等要求。

3. EN 149：2001+A1：2009 粉尘口罩标准。

该标准规定了粉尘口罩的分类、性能要求以及测试方法等。

欧盟颁布的指令主要包括：1. 93/42/EEC 医疗器械指令。

该指令规定了口罩、呼吸器以及类似的医疗器械的标准和提供者的责任。

2. 89/686/EEC 生产和销售个体防护装备指令。

该指令规定了个体防护装备的标记要求，指出了必须上面标有CE 标记。

3. 2016/425 管理个体防护装备的新指令。

该指令列举新制定的个体防护装备分类，标记和评估方法。

二、美国市场认证信息指南美国作为全球最大的市场之一，其对口罩等防疫用品的市场认证和标准也备受关注。

中美欧常用药品注册申报流程汇编-概述说明以及解释1.引言1.1 概述概述中美欧常用药品注册申报流程是指在中美欧三个地区，药品生产企业向相关政府机构提交申请材料，并经过一系列的审核与评估程序，最终获得注册批准的过程。

这一流程涉及到药品监管的法规政策、申报材料的准备、申请的提交和评估等多个环节，是确保药品质量、安全和有效性的重要环节。

本文将对中美欧常用药品注册申报流程进行深入探讨，包括背景、重要性、申报的步骤等方面的内容。

我们将通过比较中美欧三个地区的注册申报流程，分析其异同之处，为药品生产企业在国际市场上进行药品注册提供参考。

在了解中美欧常用药品注册申报流程之前，我们需要先了解药品注册的背景和其在药品监管中的重要性。

药品注册是各个国家或地区为了确保药品质量、安全和有效性所设立的一项重要制度。

通过严格的注册申报流程，相关监管机构能够对药品生产企业的生产、质量控制、药品临床试验等各个环节进行监管，从而保障人民群众的用药安全和健康。

通过本文的阐述，我们希望能够为药品生产企业提供一份中美欧常用药品注册申报流程的汇编，使其能够更加深入地理解和掌握这一流程，为其顺利进行药品注册申报提供一定的指导。

此外，我们还将对未来的发展趋势进行展望，为读者提供一些启示和思考。

接下来，我们将首先介绍中美欧药品注册的背景，为读者提供必要的背景知识。

随后，我们将探讨中美欧药品注册的重要性，阐述其在保障用药安全和质量方面的作用。

最后，我们将详细介绍中美欧常用药品注册申报流程的具体步骤，包括提交申请材料和审核评估等环节，为读者提供全面的了解。

希望通过本文的阅读，读者能够对中美欧常用药品注册申报流程有一个更加清晰的认识，并能够在实际操作中获得更好的指导和应用。

同时，我们也希望此文能够促进中美欧三个地区在药品注册方面的交流与合作，共同提升药品监管水平，为人民群众的健康和福祉做出更大的贡献。

文章结构的部分内容可以按照以下方式编写：1.2 文章结构本文按照以下结构介绍了中美欧常用药品注册申报流程：2.1 中美欧常用药品注册申报流程- 2.1.1 中美欧药品注册的背景- 2.1.2 中美欧药品注册的重要性2.2 中美欧常用药品注册申报的步骤- 2.2.1 提交申请材料- 2.2.2 审核和评估3.结论- 3.1 总结常用药品注册申报流程- 3.2 未来发展趋势通过以上结构，本文将全面介绍中美欧常用药品注册申报流程的背景、重要性，以及具体的申报步骤。

我国人类遗传资源国际合作科学研究审批申请书Title: Application for Approval of International Cooperation on Scientific Research of Human Genetic Resources in China1. Background1.1 Human genetic resources play a crucial role in scientific research, biomedical applications, and medical development. 1.2 China possesses abundant human genetic resources, which are of great value for international cooperation and exchange in the field of genetics and medicine.1.3 International cooperation on scientific research of human genetic resources in China will promote the development of genetic science and benefit the global scientificmunity.2. Purpose2.1 The purpose of this application is to seek approval for international cooperation on scientific research of human genetic resources in China.2.2 The research 本人ms to engage in collaborative studies with international partners to enhance the understanding of human genetics, disease mechanisms, and potential therapeutic targets.2.3 The ultimate goal is to contribute to the advancement ofmedical science and the improvement of public health on a global scale.3. Scientific Objectives3.1 To conduct collaborative research on the diversity of human genetic resources in China and abroad.3.2 To investigate the genetic basis of cert本人n hereditary diseases andmon disorders in different populations.3.3 To explore the potential applications of genetic knowledge in personalized medicine, disease prevention, and public health management.3.4 To establish a framework for ethical and responsible use of human genetic resources in scientific research and medical practice.4. Research Plan4.1 The research will involve the collection of human genetic samples from diverse ethnic groups and geographic regions in China.4.2 The samples will be subjected toprehensive genetic analysis, including whole-genome sequencing, gene expression profiling, and bioinformatics analysis.4.3 Collaborative studies will be conducted topare the geneticdata with international databases and research findings, 本人ming to identify genetic variations and disease-related genes.4.4 Ethical principles and legal regulations regarding the collection, storage, and use of human genetic resources will be strictly adhered to throughout the research process.5. Collaborative Partners5.1 This international cooperation will involve collaboration with prestigious research institutions, hospitals, and universities from around the world.5.2 The partners will contribute their expertise in genetics, genomics, bioinformatics, and clinical research to the joint research projects.5.3 The exchange of knowledge, technologies, and resources will be facilitated to maximize the scientific output and impact of the collaborative research.6. Expected Oues6.1 The research oues will advance the understanding of human genetic diversity, evolutionary history, and disease susceptibility in different populations.6.2 The identification of genetic markers and disease-related genes will provide valuable insights into precision medicine andtargeted therapy development.6.3 The findings and discoveries will be disseminated through scientific publications, conference presentations, and public outreach activities to promote global knowledge sharing and application.7. Ethical Considerations7.1 The research will strictly adhere to ethical guidelines and regulations concerning the use of human genetic resources, including informed consent, data confidentiality, and protection of participants' rights and privacy.7.2 The research activities will be conducted in accordance with the principles of beneficence, non-maleficence, justice, and respect for autonomy, ensuring the ethical conduct of all research procedures.7.3 The research team will engage in activemunication and collaboration with localmunities and relevant stakeholders to ensure the ethical and responsible conduct of the research activities.8. Regulatory Compliance8.1 The research willply with the relevant laws, regulations, and international conventions on human genetic resources,biosafety, and bioethics.8.2 All necessary permits, approvals, and ethical reviews frompetent authorities and ethicsmittees will be obt本人ned before themencement of the research activities.8.3 The research team will m本人nt本人n transparency, accountability, and regulatorypliance throughout the research process, and provide regular updates and reports to relevant authorities and oversight bodies.9. Conclusion9.1 International cooperation on scientific research of human genetic resources in China holds great promise for advancing the frontiers of genetic science, medical innovation, and global health.9.2 The collaborative research endeavors will contribute to the mutual benefit of scientificmunities, healthcare systems, and human well-being worldwide.9.3 The ethical, responsible, and regulatorypliant conduct of the research will ensure the sust本人nable and socially responsible development of human genetic research and applications.10. Research TeamPrincipal Investigator: [Name]Affiliation: [Institution]Co-Investigators: [Names] Affiliation: [Institutions]Contact Information: [Em本人l Address] Date: [Date]End of Application.。

欧洲专利局决议利于专利申请人提出申诉作者：米开拉•莫迪亚罗来源：《中国知识产权》2013年第06期在成立了40年后，欧洲专利局（EPO）近来终于引入了申诉机制（官方名称为“复查申请书”），通过此机制可对欧洲专利局上诉委员会的决定提出申诉。

若无此机制，上诉委员会的决定将会是最终决定，而且这种决定往往对败诉方产生非常重大的影响。

在极特殊的情况下，若申请人认为上诉委员会本身的程序性错误影响了其最终决定，可通过此机制提出申诉。

这项重要的法律变更生效后，已有数个复审申请书提交到欧洲专利局，但成功者甚少。

然而，欧洲专利局最近的一项决议事实上重新开启了针对某个特定欧洲申请的上诉程序（该申请已经被审查部和上诉委员会驳回），因为该局发现上诉委员会未能尊重此案申请人获得审理的权利。

这对于申请人来说是个好消息，若非如此，上诉委员会的决定将变成最终决定，而该申请也早已被驳回。

该案例的细节如下：在上诉结案审理上，申请者获准首先讨论主要的诉讼请求，在主要请求不予支持的情况下，讨论辅助的诉讼请求。

在讨论辅助性请求时，申请人已经说明（可能的）异议在于原申请是否支持辅助性请求以及原申请是否具有发明特性。

申请人并未涉及到清晰性，因为在上诉程序中这方面的请求似乎并未“直接”涉及到相关内容。

然而，上诉委员会正是因为其辅助请求不符合清晰性的相关要求，而决定拒绝其辅助性请求（从而明确拒绝所有申请）。

而且，在给申请人机会对反对意见做出说明前，上诉委员就做出了这个决定。

有趣的是，欧洲专利局决定批准复审申请书并重新开启申诉程序，主要基于以下观点：“上诉委员会在起草相关文本时，应当充分考虑所有递交的文件，从而使申请者能够认定案件获得审理的权利……得到了尊重，因为上诉委员会是基于充分依据而做出的决定。

”因此，在这种情况下，欧洲专利局决定由上诉委员会来证明其并未侵犯案件获审的权利，并要求上诉委员会在复审申请书提出前就承担起此项举证任务，而不是让申请人完全承担此项举证任务而上诉委员只是将重点放在针对复审申请进行自我辩护上。

申请美国商标需要的资料以及流程是怎样的？申请美国商标的时间：2-4个周申请美国商标需要的资料：1.申请人的身份证、营业执照（中、英文名称及地址）2.商品或服务项目（采用《商标注册用商品和服务国际分类尼斯协定》。

）3.商标图样：清晰商标图样，电子版LOGO（JPG格式）。

注：若商标为彩色，请指定颜色，以后使用将按照指定颜色使用；若商标为黑白，以后可使用任意颜色4.一份《注册美国商标委托书》填写一个文字商标及一个类别的商品或服务项目。

5.本国商标注册证明文件、最早在美国使用的日期及证据申请美国商标需要的条件：1. 商标拥有人的全名和地址。

2. 所要占有的商品或服务的名称（商标申请类别）3. 商标样本以jpg档案格式电邮给本司。

4.杂费（包括银行手续费和翻译费）如何申请美国商标？1、美国商标申请书一份;2、美国商标图样一份，规格为4×4CM至10×10CM;3、美国商标的类别及产品描述;4、如所申请之商标为目前已经使用，则每个类别的商品或服务需提交三份样本，显示该商标在该商品或服务上的实际使用情况，可为同一商标在同一商品上，或同一商标在不同的三种商品上使用的示例。

申请美国商标的好处：1、便于消费者认牌购物。

2、商标注册人拥有商标专用权, 受法律保护。

3、通过商标注册，可以创立品牌，抢先占领市场。

4、商标是一种无形资产，可对其价值进行评估。

5、商标可以通过转让，许可给他人使用，或质押来转换实现其价值。

6、商标还是办理质检、卫检、条码等的必备条件。

申请美国商标的程序：1.申请美国商标美国专利局(以下简称为：TPO)负责联邦政府的商标注册。

收到注册申请后，TPO 会进行形式审查以确定其是否符合商标注册的基本要求。

如果符合，TPO会签发日期并在提交申请两个月后发给申请人一份通知书。

如果不符合要求，则将所有材料包括申请费全部退还给申请人2.审查美国商标在提交申请四个月后，TPO的审查员将负责审查并决定该商标能否注册。

MVol ReguCONTAmplifierSCIFuel Pressure Current Sensing, Rotor Position, Angle SensingSmartRectifier™IR1166/67: Simple, High Efficiency Sync RecFor de signe rs of high powe r flyback and re sonant half-bridge conve rte rs for laptops, mini-PCs, LCD and PDP TVs and games, the SmartRectifier™ offers a simple, high efficien-cy solution for se condary synchronous re ctification (SR) in all ope rational mode s and application conditions.IR1166/67 can be used with IR’s HEXFET®PowerNo manual assemblyThe µPFC TM Family of Controller ICs Alters Traditional Thinking About PFC SolutionsThe IR1150 uses a new, patented "One-Cycle Control (OCC), integrator with reset" tech-nique to deliver the high performance of Continuous Conduction Mode (CCM) PFC with the simplicity and low component count of Discontinuous Current Mode (DCM).OCC doe s not have the traditional analog multiplie r, AC line se nsing or fixe d oscillator ramp. In OCC the output of the error amplifier is integrated over each clock cycle to gen-erate a variable-slope ramp. This variable ramp is compared with the error voltage and subtracted from the current sense signal to generate the PWM gate drive.The IRS2092 is an inte grate d drive r IC fe aturing prote cte d PWM switching for me diumpower, high performance Class D audio amplifiers up to 500W in home theatre, home stereo,active speaker, musical instrument, and professional audio applications.Based upon a half bridge topology, the new audio driver IC integrates four essential func-tions for Class D design implementation including error amplifier, PWM comparator, gatedriver, and robust protection circuitry. As a result, this compact 16-pin IC offers high noiseimmunity, reduced start and stop click noise, and design scalability, while greatly reducingsome of the most complicated and costly design tasks such as overload protection. Motion Control Current Sensing ICsThe IR217x/IR227x is a family of monolithic current sensing ICs designed for motor drive applications. The ICs sense the motor phase current through an external shunt resistor, convert the current information from an analog to a digital signal, and transfer the signalHigh Voltage Gate Driver ICs (HVICs)International Rectifier's MOSFET and IGBT gate driver ICs are the simplest, smallest andlowest cost solution to drive MOSFETs or IGBTs up to 1200V in applications up to 12kW,and can save over 30% in part count in a 50% smaller PCB area compared to a discreteopto-couple r or transforme r-base d solution. With the addition of fe w e xte rnal compo-ne nts, IR gate drive r ICs provide full drive r capability with e xtre me ly fast switching HVICIR Gate Driver ICs Simplify Design (continued)These ICs simplify circuit designs by integrating extensive functionality. They use a low cost bootstrap supply, while opto-couple r-base d circuits typically re quire an auxiliary powe supply. IR Gate Driver ICs offer optional single input or dual input programmable deadtime control for low-side and high-side drivers as well as for 3-phase drivers to provide design flexibility and minimize cross-conduction.HVICs with advanced over-current detection and protection circuitryMulti-chip modules, like the iPOWIR™ intelligent scalable building blocks integrate critical power, drive and control silicon, simplify de sign while raising the e fficie ncy and curre nt density of on-board power converters for the latest generation of low-voltage processors in single- and multiphase topologies. IR's expertise in device matching and "short trace" lay-out deliver this optimized solution that combines multiple power semiconductors, ICs, and passive components into a single package. The iPOWIR MCMs require less developmentThe iP200x series family is a functional “building block” for multiphase buck converters which are use d to powe r GHz class CPUs in high-e nd computing and commun-ications syste ms. Base d on Inte rnational Re ctifie r’s iPOWIR™te chnology, the iP200x integrates the power semiconductors, a driver IC and layout-critical passives required for each phase of a multiphase synchronous buck converter into a single package. These products are offered in either ball grid array (BGA) or land grid array (LGA).LED Lighting Solution 3HB-LEDs fe ature huge longe vity, low mainte nance re quire me nt, small size, de sign flexibility, de corative e ffe ct capability, safe low DC voltage ope ration, e xce lle nt cold we athe r pe rformance, lack of me rcury, supe rior color gamut and brightne ss are making LEDs extremely popular. IR offers dedicated control ICs which can use at best all the LEDs features either in a DC-DC environment or directly off-line. Furthermore IR ICs offers a high degree of integration, minimizing the design time needed and increas-Features at a GlanceIR2161 Halogen •Intelligent Half Bridge DriverHID Lighting Solutions Thanks to key advantages over other light sources (high lumen output, long life, color ren-dering and “point of light”), HID lamps are gaining in popularity in the industrial world. From few tens of watts for shop lights, to several hundreds of watts for street lighting, IR ICs offer a high degree of integration, minimizing the design time needed and increasing ballast reli-ability. The traditional industrial topology includes a PFC front-end, a buck converter to reg-ulate the current, and a full-bridge switching a 50% inverting the polarity.ICICICEMI FilterEMI FilterRectifierHalf-BridgeOutput Stage RectifierHalf-BridgePFCLineLine LIGHTING Halogen Ballast ConfigurationLIGHTING Linear Fluorescent Ballast ConfigurationExponential growth in the requirements for higher current at lower operating voltages has created a rough road for designers of DC-DC power management systems. International Rectifier has focused the power semiconductor industry's largest R&D effort to implement a roadmap for high performance and cost-effective DC-DC power management. IR's exten-sive discrete and IC portfolio makes IR the only power semiconductor company with a prod-The Scalable, Flexible Multiphase ArchitectureThe XPhase chip set consists of the control IC, containing all the one-per-converter circuit-ry, and a scalable array of phase converters, each using a single phase IC with all the one-per-phase circuitry.ApplicationsReal-time Power Monitoring ICThe IR3721 output power monitor IC for low-voltage DC-V IN DC converters used in notebook, desktop computers, ande ne rgy-e fficie nt se rve r applications, utilize s IR’s pate nt-pe nding True Powe r™ te chnology to accurate ly capture highly dynamic power information with 2.5 percent accu-racy at 65°C.Buck versus two top monolithic, lateral FETsSave Energy; Simplify Embedded Power Designs; Shrink Silicon Footprint by 70%The innovative SupIRBuck family of point-of-load (POL) voltage regulators integrates IR’shigh performance synchronous buck control ICs and benchmark HEXFET® trench technol-ogy MOSFETs in a compact 5mm by 6mm Power QFN package, shrinking the silicon footprintby 70 percent compared to discrete solutions, and offering up to ten percent higher full-loadefficiency than competing monolithic ICs.All WARP2 IGBTs are offered with co-pack HEXFRED diodes, which offer excellent reverse recovery characteristics, much better than the integral diodes in a Power MOSFET.The improvement in switching performance, combined with the positive thermal coefficientThe IPMs are an addition to the iMOTION™ family of integrated design platforms from IR. Together with a few external components and our digital controllers, they form a complete motor drive system, greatly accelerating the design path compared to a multi-discrete solu-r-curre nt prote ction, along with short-circuit rate d IGBTs, an integrated under-voltage lockout function, and built-in temperature monitor pro-Ultra-Low R DS(on)Self-Protected Intelligent Power SwitchesIntelligent Power Switches (IPS) from International Rectifier integrate a low R DS(on) output HEXFET®power MOSFET into a single package with protection and control circuits, makingInternational Rectifier Microelectronic RelaysInternational Rectifier microelectronic relays consist of HEXFET® power MOSFET and IGBT output photovoltaic relays, as well as a line of photovoltaic isolators. The operating param-eters of photovoltaic relays are ideal for switching low-level signal loads in instrumentation and data acquisition to medium power loads in industrial controls and process automation,Inte rnational Re ctifie r automotive Tre nch HEXFET®Powe r MOSFETs fe atureimproved efficiency, switching performance and ruggedness compared to competi-tive Trench technology. IR Trench process has been uniquely optimized to extend thebenefits of Trench technology to the harsh automotive environment without sacrific-ing the avalanche rugge dne ss that automotive syste m de signe rs have come toexpect from IR’s planar MOSFETs.TrenchThe International Rectifier DirectFET power packageThe Inte rnational Re ctifie r Dire ctFET powe r package is a bre akthrough surface-mount power MOSFET packaging technology designed for efficient topside cooling in a SO-8 foot-print. In combination with improved bottom-side cooling, the new package can be cooled on both sides to cut part count by up to 60%, and board space by as much as 50% comparedfrom electrical and thermal point of view features. The Discovery Center is organized in the following sections:•DirectFET MOSFET Overview features a complete and deep description of the。