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11501150 单词,单词,70007000 英文字符,英文字符,24002400 汉字汉字 出出处处:VesperVesper J, J, KartogluKartoglu , , BisharaBishara R,R, etet al.al. A A casecase studystudy in in experientialexperiential learning:learning: pharmaceutical cold chain management on wheels.J. Journal of Continuing Education in thepharmaceutical cold chain management on wheels.J. Journal of Continuing Education in the Health Professions, 2010, 30(4):229Health Professions, 2010, 30(4):229 236.236. 原文原文 A Case Study in Experiential Learning: Pharmaceutical Cold ChainA Case Study in Experiential Learning: Pharmaceutical Cold Chain Management on WheelsManagement on Wheels VESPER, KARTO, RAFIK , THOMAS AbstractAbstract People who handle and regulate temperature-sensitive pharmaceutical products require the knowledge and skills to ensure those products maintain quality, integrity, safety, and efficacy throughout their shelf life. People best acquire such knowledge and skills through “experiential learning” that involves working with other learners and experts. The World Health Organization developed a weeklong experiential learning event for participants so they could gain experience in how temperature-sensitive products are handled, stored, and distributed throughout the length of the distribution supply chain system. This experiential learning method enabled participants to visit, critically observe, discuss and report on the various components of the cold chain process. An emphasis was placed on team members working together to learn from one another and on several global expert mentors who were available to guide the learning, share their experiences, and respond to questions. The learning event, Pharmaceutical Cold Chain Management on Wheels, has been conducted once each year since 2008 in Turkey with participants from the global pharmaceutical industry, health care providers, national regulatory authorities, and suppliers/vendors. Observations made during the course showed that it was consistent with the principles of experiential and social learning theories. Questionnaires and focus groups provided evidence of the value of the learning event and ways to improve it. Discussion: Reflecting the critical elements derived from experiential and social learning theories, five factors contributed to the success of this unique experiential learning event. These factors may also have relevance in other experiential learning courses and, potentially, for experiential e-learning events. KeyKey Words:Words: experiential learning, social learning, pharmaceutical cold chain, handling of pharmaceutical products IntroductionIntroduction Cold Chain DescribedCold Chain Described Many pharmaceutical products are temperature-sensitive and must be stored and transported at controlled temperaturesfor instance, 2 to 8 degrees Centigrade. Exposure to temperatures outside the recommended range can result in damage to the product and cause safety issues or lack of effectiveness. A “cold chain” is the integrated system of equipment (eg, cold rooms, shipping containers, refrigerators, and vehicles), procedures, records, and activities used to handle, store, transport, distribute, and monitor temperature-sensitive products. The allusion to a chain is apt. As with a physical chain, a cold chain is only so strong as its weakest link. People are a critical element of a cold chain. They must correctly execute procedures and take appropriate actions in the event of a problem.Beyond the people directly involved in the cold chain are those who design and develop equipment and devices used in handling pharmaceutical products. Everyone involved must have the appropriate knowledge and skills to perform their jobs, as well as a vision of how the whole handling operation can be maintained and enhanced. The Need for Knowledge and SkillsThe Need for Knowledge and SkillsThe ProblemThe Problem The World Health Organizations Global Learning Opportunities for Vaccine Quality (previously called Global Training Network) recognized the need to develop the knowledge and skills of those involved in the pharmaceutical cold chain. Specifically, the challenge was how to provide an engaging learning event for manufacturers, health care providers, regulators, and other partners in the supply chain of temperature-sensitive products so they could critically evaluate a pharmaceutical “cold chain” system to ensure the quality, integrity, safety, and efficacy of the pharmaceutical product to the patients. Learning through Experiences with OthersLearning through Experiences with OthersThe SolutionThe Solution Acquiring knowledge and skills from experience is one important method for developing competence in a task, occupation, or profession. Internships, clinical rotations, and practicums are examples of experiential learning, a highly regarded component of adult learning theory. Kolb defined experiential learning as “The process whereby knowledge is created through the transformation of experience. Knowledge results from the combination of grasping and transforming experience.” FIGURE 1 depicts Kolbs cycle as modified by Boisot. These stages form a dynamic learning cycle that a learner can enter at any stage, based on the unique characteristics of the individual. The four stages can be categorized into two sets of activities. First, concrete experience and abstract conceptualization occur when the learner “grasps” experiences. Second, reflective observation and active experimentation allow the learner to transform experience into knowledge and skill. MethodsMethods The developers of the PCCMoW course looked for ways that would be richer and more engaging than a series of illustrated lectures. Specifically, they looked for ways that a group of participants ranging from regulatory authorities to health care providers from around the world could share their knowledge and learn together while working on authentic tasks. Participants represented a variety of roles within the cold chain, such as national regulatory authorities; manufacturing and quality assurance personnel from the pharmaceutical, biopharmaceutical, and vaccineindustries;healthcareprofessionalswhoadministertemperature-sensitive pharmaceuticals; and others involved in the supply, packaging, distribution, logistics, and cold chain management areas. Additionally, the intent was to form a learning community that extended beyond the conclusion of the course. Therefore, a password-protected alumni community was developed wherein members cooperate and support each other via e-mail and online discussions as well as at conferences focused on cold-chain topics. Enrollment in eachPCCMoW course is limited to 15 participants carefully selected by the course director. Three mentors with extensive, comprehensive experience in the international pharmaceutical industry support the participants throughout the course by coaching participants during their assignments, facilitating discussions following presentations, sharing best practices, and guiding the group toward sound conclusions. The course encourages participants to make direct observations at the storage, warehousing, distribution, and health care delivery facilities that they visit, as they physically travel with mentors by bus down the length of the cold chain. Throughout the course, guided observation exercises take place at the visited facilities under the supervision of the mentors. Participants are provided with guidance notes and tools to support their critical observations. Participants inter- act with operational staff and management at these facilities. Presentations and group discussions take place on the bus, in restaurants, and in the open air before and after the visits to the facilities. Turkey was selected as the course venue in part because of the availability of the tour coordinator who arranged the logistics and helped with the extensive planning required. ResultsResults The PCCMoW course exhibits many attributes of experiential and social learning, consistent with the work of Kolb and Vygotsky.In Kolbs four-stage model, learners may enter the process at any point, in part based on the individuals learning style. For simplicity, we will enter the process at the Concrete Experience stage. ConclusionConclusion In examining the PCCMoW course, we see that its design and execution include the four aspects of experiential learning identified by Kolb and two important elements of social learning described by Vygotsky. We found some evidence that course participants were able to apply the knowledge and skills they acquired during the course in their jobs and practices. We identified 5 critical success factors necessary for an effective experiential learning course. Participant feedback indicates that a well-designed and executed experiential learning event can make an indelible mark on the participants. 译文译文 一个案例研究:药品冷链物流运输管理一个案例研究:药品冷链物流运输管理 维斯珀;卡特;拉菲克;托马斯 摘要摘要 操作和管理热敏医药产品的人需要具备一定的知识和技能, 以确保这些产品在它们 的保质期内的质量、完整性、安全性和有效性。相关人员最好通过“体验式学习,多参 与这方面的管理实践”获得这种知识和技能,包括与其他同门和专家一起工作。 世界卫生组织了为期一周的体验学习活动, 那些参与者们可以通过这次实践活动获 得关于如何处理、 储存热敏产品等经验。 这个实践体验法可以使参与者实地学习, 考察、 讨论和分享药品冷链管理过程。重点是团队成员一起努力,互相学习,并且还有来自全 球范围内的几个专家来指导学习,分享他们的经验并回答相关问题。 医药冷链物流运输管理,自 2008 年以来,在土耳其就已经举行过类似的实践培训 活动,参与者来自于全球各地制药行业的行业人士,以及卫生保健提供者、国家监管部 门和供应商等。通过医药冷链物流运输管理实践,大家一致认为,都较好地掌握了医药 冷链物流运输管理方面的技能和知识。 问卷调查等方法获得的研究结果为以后的医药冷 链物流运输的改善提供了实证案例证据。 反映经验和社会学习理论的关键因素,五个因素促成了这一独特体验式学习活动的 成功。这些因素也可能与其他经验学习课程有关,并可能与经验性的学习活动有关。 关键词:关键词:实践活动;药物冷链物流;药品操作处理 引言引言 冷链描述冷链描述 许多医药品都是属于热敏性的, 因此, 必须要对它们的存储和运输加以控制, 比如, 温度要控制在 2 - 8 摄氏度。暴露在超过推荐温度外的话,就很可能会导致损坏产品, 导致缺乏有效性等一系列的安全问题。 “冷链”是一个设备、过程记录、处理、贮存、运输、分发和监控等组成的集成系 统 (如:寒冷的房间、集装箱、冰箱和车辆),用于热敏性药品的操作,储存,运输等。 用一个链来形容这一过程是恰当的。它就是一个物理链, 冷链的强弱取决于链中最薄弱 的一环。 人在这一冷链中,是一个关键要素。他们必须正确地执行程序和采取适当的行动, 当出现问题时。除了直接参与冷链管理工程的人,那些设计和开发药品冷链设备的人员 也是很重要的。每个人都必须有适当的知识和有关药品冷链处理技能,只有这样,整个 药品冷链的效果才能得到保持和增强。 知识和技能的必要性问题知识和技能的必要性问题 世界卫生组织曾安排了全球范围内的疫苗储存管理质量方面的培训活动, 旨在提高 制药冷链中相关参与人员的药品管理知识和具体操作技能。具体来说, 就是培养他们作 为一个合格的药品制造商、医疗保健提供者、药品管理者和热敏药品供应链中其他合作 伙伴的技能。 这样他们就可以正确的操作药物 “冷链” 系统, 从而保证热敏药品的质量、 完整性、安全性和疗效。 通过行业内互相交流掌握技能通过行业内互相交流掌握技能 行业内部的经验分享对于药品冷链管理者来说是一个很好的加强药品冷链管理技 能的途径。实习、临床轮换等被认为是从业人员掌握技能的重要过程。科尔布就非常赞 同你这种观点,它也认为你这种体验实践学习,可以很好地转化为自身的经验,对于参 与者来说,可以获得实实在在的效果。 这些阶段形成了一个动态的药品冷链管理学习周期, 行业从业者也可以在任何阶段 开始学习,掌握自己需要掌握的该方面的技能。这四个阶段可以被归类,并分成两组活 动。首先,根据自己的感知掌握相关理论和概念。第二,通过观察和互相交流,得到间 接的知识和技能。 研究方法研究方法 药品冷链物流运输课程的开发者们寻找出最合适的方法, 相比于一般的讲座,更加 的丰富和更吸引人,能够

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