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1、<p>  1150單詞,7000英文字符,2400漢字</p><p>  出處:Vesper J, Kartoglu Ü, Bishara R, et al. A case study in experiential learning: pharmaceutical cold chain management on wheels.[J]. Journal of Continuing Edu

2、cation in the Health Professions, 2010, 30(4):229–236.</p><p><b>  原文 </b></p><p>  A Case Study in Experiential Learning: Pharmaceutical Cold Chain Management on Wheels </p>

3、<p>  VESPER, KARTO, RAFIK , THOMAS</p><p><b>  Abstract </b></p><p>  People who handle and regulate temperature-sensitive pharmaceutical products require the knowledge and ski

4、lls 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 ot

5、her learners and experts. </p><p>  The World Health Organization developed a weeklong experiential learning event for participants so they could gain experience in how temperature-sensitive products ar

6、e 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 variou

7、s components of the cold chain process. An emphasis was placed on team members working together to learn from one anoth</p><p>  The learning event, Pharmaceutical Cold Chain Management on Wheels, has b

8、een 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 th

9、e 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<

10、;/p><p>  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 m

11、ay also have relevance in other experiential learning courses and, potentially, for experiential e-learning events.</p><p>  Key Words: experiential learning, social learning, pharmaceutical cold chain, hand

12、ling of pharmaceutical products </p><p>  Introduction </p><p>  Cold Chain Described </p><p>  Many pharmaceutical products are temperature-sensitive and must be stored and transpo

13、rted at controlled temperatures—for 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.&#

14、160;</p><p>  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, di

15、stribute, 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. </p><p>  People are a criti

16、cal 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 equi

17、pment 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 main

18、tained and enhanced. </p><p>  The Need for Knowledge and Skills—The Problem </p><p>  The World Health Organization’s Global Learning Opportunities for Vaccine Quality (previously called G

19、lobal 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 manuf

20、acturers, health care providers, regulators, and other partners in the supply chain of temperature-sensitive products so they could critically evaluate a pharmaceutical “cold chain” s</p><p>  Learning throu

21、gh Experiences with Others—The Solution </p><p>  Acquiring knowledge and skills from experience is one important method for developing competence in a task, occupation, or profession. Internships, clin

22、ical 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

23、 transformation of experience. Knowledge results from the combination of grasping and transforming experience.” FIGURE 1 depicts Kolb</p><p>  These stages form a dynamic learning cycle that a learner c

24、an 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

25、 the learner “grasps” experiences. Second, reflective observation and active experimentation allow the learner to transform experience into knowledge and skill. </p><p><b>  Methods </b>

26、;</p><p>  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 participan

27、ts 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 with

28、in the cold chain, such as national regulatory authorities; manufacturing and quality assuranc</p><p>  Additionally, the intent was to form a learning community that extended beyond the conclusion of the co

29、urse. 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. &l

30、t;/p><p>  Enrollment in each PCCMoW course is limited to 15 participants carefully selected by the course director. Three mentors with extensive, comprehensive experience in the international pharmaceutical i

31、ndustry 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 concl

32、usions.</p><p>  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

33、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 not

34、es and tools to support their critical observations. Participants inter- act with operatio</p><p><b>  Results </b></p><p>  The PCCMoW course exhibits many attributes of experientia

35、l and social learning, consistent with the work of Kolb and Vygotsky. In Kolb’s four-stage model, learners may enter the process at any point, in part based on the individual’s learning style. For simplicity, w

36、e will enter the process at the Concrete Experience stage. </p><p>  Conclusion </p><p>  In examining the PCCMoW course, we see that its design and execution include the four aspects of ex

37、periential 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 d

38、uring 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</p><p><

39、;b>  譯文 </b></p><p>  一個案例研究:藥品冷鏈物流運(yùn)輸管理</p><p>  維斯珀;卡特;拉菲克;托馬斯</p><p><b>  摘要 </b></p><p>  操作和管理熱敏醫(yī)藥產(chǎn)品的人需要具備一定的知識和技能,以確保這些產(chǎn)品在它們的保質(zhì)期內(nèi)的質(zhì)量、完整性、安全性和有

40、效性。相關(guān)人員最好通過“體驗(yàn)式學(xué)習(xí),多參與這方面的管理實(shí)踐”獲得這種知識和技能,包括與其他同門和專家一起工作。 </p><p>  世界衛(wèi)生組織了為期一周的體驗(yàn)學(xué)習(xí)活動,那些參與者們可以通過這次實(shí)踐活動 獲得關(guān)于如何處理、儲存熱敏產(chǎn)品等經(jīng)驗(yàn)。這個實(shí)踐體驗(yàn)法可以使參與者實(shí)地學(xué)習(xí),考察、討論和分享藥品冷鏈管理過程。重點(diǎn)是團(tuán)隊成員一起努力,互相學(xué)習(xí),并且還有來自全球范圍內(nèi)的幾個專家來指導(dǎo)學(xué)習(xí),分享他們的經(jīng)驗(yàn)并回答相關(guān)

41、問題。 </p><p>  醫(yī)藥冷鏈物流運(yùn)輸管理,自 2008 年以來,在土耳其就已經(jīng)舉行過類似的實(shí)踐培訓(xùn)活動,參與者來自于全球各地制藥行業(yè)的行業(yè)人士,以及衛(wèi)生保健提供者、國家監(jiān)管部門和供應(yīng)商等。通過醫(yī)藥冷鏈物流運(yùn)輸管理實(shí)踐,大家一致認(rèn)為,都較好地掌握了醫(yī)藥冷鏈物流運(yùn)輸管理方面的技能和知識。問卷調(diào)查等方法獲得的研究結(jié)果為以后的醫(yī)藥冷鏈物流運(yùn)輸?shù)母纳铺峁┝藢?shí)證案例證據(jù)。</p><p> 

42、 反映經(jīng)驗(yàn)和社會學(xué)習(xí)理論的關(guān)鍵因素,五個因素促成了這一獨(dú)特體驗(yàn)式學(xué)習(xí)活動的成功。這些因素也可能與其他經(jīng)驗(yàn)學(xué)習(xí)課程有關(guān),并可能與經(jīng)驗(yàn)性的學(xué)習(xí)活動有關(guān)。 </p><p>  關(guān)鍵詞:實(shí)踐活動;藥物冷鏈物流;藥品操作處理 </p><p><b>  引言 </b></p><p><b>  冷鏈描述 </b></p&

43、gt;<p>  許多醫(yī)藥品都是屬于熱敏性的,因此,必須要對它們的存儲和運(yùn)輸加以控制,比如,溫度要控制在 2 - 8 攝氏度。暴露在超過推薦溫度外的話,就很可能會導(dǎo)致?lián)p壞產(chǎn)品,導(dǎo)致缺乏有效性等一系列的安全問題。 </p><p>  “冷鏈”是一個設(shè)備、過程記錄、處理、貯存、運(yùn)輸、分發(fā)和監(jiān)控等組成的集成系統(tǒng) (如:寒冷的房間、集裝箱、冰箱和車輛),用于熱敏性藥品的操作,儲存,運(yùn)輸

44、等。用一個鏈來形容這一過程是恰當(dāng)?shù)?。它就是一個物理鏈,冷鏈的強(qiáng)弱取決于鏈中最薄弱的一環(huán)。 </p><p>  人在這一冷鏈中,是一個關(guān)鍵要素。他們必須正確地執(zhí)行程序和采取適當(dāng)?shù)男袆?,?dāng)出現(xiàn)問題時。除了直接參與冷鏈管理工程的人,那些設(shè)計和開發(fā)藥品冷鏈設(shè)備 的人員也是很重要的。 每個人都必須有適當(dāng)?shù)闹R和有關(guān)藥品冷鏈處理技能,只有這樣,整個藥品冷鏈的效果才能得到保持和增強(qiáng)。 </p><p>

45、;  知識和技能的必要性問題 </p><p>  世界衛(wèi)生組織曾安排了全球范圍內(nèi)的疫苗儲存管理質(zhì)量方面的培訓(xùn)活動,旨在提高制藥冷鏈中相關(guān)參與人員的藥品管理知識和具體操作技能。具體來說,就是培養(yǎng)他們作為一個合格的藥品制造商、醫(yī)療保健提供者、藥品管理者和熱敏藥品供應(yīng)鏈中其他合作伙伴的技能。這樣他們就可以正確的操作藥物“冷鏈”系統(tǒng),從而保證熱敏藥品的質(zhì)量、完整性、安全性和療效。 </p><p&g

46、t;  通過行業(yè)內(nèi)互相交流掌握技能 </p><p>  行業(yè)內(nèi)部的經(jīng)驗(yàn)分享對于藥品冷鏈管理者來說是一個很好的加強(qiáng)藥品冷鏈管理技能的途徑。實(shí)習(xí)、臨床輪換等被認(rèn)為是從業(yè)人員掌握技能的重要過程。科爾布就非常贊同你這種觀點(diǎn),它也認(rèn)為你這種體驗(yàn)實(shí)踐學(xué)習(xí),可以很好地轉(zhuǎn)化為自身的經(jīng)驗(yàn),對于參與者來說,可以獲得實(shí)實(shí)在在的效果。 </p><p>  這些階段形成了一個動態(tài)的藥品冷鏈管理學(xué)習(xí)周期,行業(yè)從業(yè)

47、者也可以在任何階段開始學(xué)習(xí),掌握自己需要掌握的該方面的技能。這四個階段可以被歸類,并分成兩組活動。首先,根據(jù)自己的感知掌握相關(guān)理論和概念。第二,通過觀察和互相交流,得到間接的知識和技能。 </p><p><b>  研究方法 </b></p><p>  藥品冷鏈物流運(yùn)輸課程的開發(fā)者們尋找出最合適的方法,相比于一般的講座,更加的豐富和更吸引人,能夠讓行業(yè)參與者們主動

48、地學(xué)習(xí),掌握藥品冷鏈管理相關(guān)技能。具體地說,他們講求實(shí)事求是,避免就理論而說理論,注重管理實(shí)踐,組織者們尋找了一群行業(yè)有名的專家們,對來自 世界各地的監(jiān)管機(jī)構(gòu)衛(wèi)生保健等方面的業(yè)內(nèi)人士進(jìn)行系統(tǒng)的講解,分享知識和技能。參與者們都來自于藥品冷鏈物流供應(yīng)鏈的各階段代表,有國家監(jiān)管部門的,有負(fù)責(zé)藥品生產(chǎn)和質(zhì)量的,有來自于疫苗產(chǎn)業(yè)的、衛(wèi)生保健方面的專業(yè)人士、以及管理熱敏制藥的人員等等,他們都或多或少地參與供應(yīng)、包裝、配送、運(yùn)輸、倉儲等藥品冷鏈管理各

49、個階段呢。 </p><p>  正如前文所說,良好的藥品冷鏈物流管理,最重要的是人,這也是最基礎(chǔ)的前提條件,因此,必須對這些參與們加以培訓(xùn),參與者自身也要在日常的從事藥品冷鏈管理的過程中,不斷地磨練自己的技能,并和同行互相交流經(jīng)驗(yàn),共同進(jìn)步,相互支持。</p><p>  藥品冷鏈物流運(yùn)輸課程的注冊人數(shù)限制為課程主任精心挑選的15名學(xué)員。在學(xué)員的任務(wù)期間,有三名在國際制藥業(yè)有廣泛、全面的

50、經(jīng)驗(yàn)的導(dǎo)師進(jìn)行輔導(dǎo),促進(jìn)普雷森博士的討論,分享最佳做法,指導(dǎo)小組取得良好的結(jié)論。</p><p>  本課程鼓勵參與者直接訪問他們所訪問的倉儲、倉儲、配送和保健服務(wù)設(shè)施,因?yàn)樗麄冊诼猛局信c導(dǎo)師一起通過冷藏鏈的長度進(jìn)行長途旅行。整個過程中,在導(dǎo)師的監(jiān)督指導(dǎo)下觀察演習(xí)所訪問的設(shè)施。與會者提供指導(dǎo)筆記和工具,以支持他們的批判性觀察。參與者、操作人員和管理人員在巴士,餐館演示和小組討論看到的露天設(shè)施。土耳其被選為課程的一

51、部分,是因?yàn)楹笄趨f(xié)調(diào)員的安排和規(guī)劃要求。</p><p><b>  研究結(jié)果 </b></p><p>  通過對藥品冷鏈物流管理的各階段參與者們的培訓(xùn),他們都能夠彌補(bǔ)自己對了藥品冷鏈物流方面的知識和技能方面的不足,不斷地改善自己的操作技能,以便在往后的藥品冷鏈物流管理工作中,更加的符合工作要求,更好地做好藥品冷鏈物流管理工作,對這些參與者們來說,最重要的,也是最實(shí)

52、用的就是,讓他們掌握真正的實(shí)際操作技能。 </p><p><b>  結(jié)論 </b></p><p>  關(guān)于對藥品冷鏈物流運(yùn)輸管理中的從業(yè)人員的技能訓(xùn)練,我們發(fā)現(xiàn),技能訓(xùn)練的設(shè)計和執(zhí)行,主要包括四個方面的,這四個方面可以被分為兩類。首先,根據(jù)自己的感知掌握相關(guān)理論和概念。第二,通過觀察和互相交流,得到間接的知識和技能。這兩個元素都是很重要的,都是藥品冷鏈物流運(yùn)輸管

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