政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/118646

政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/118646

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政大機構典藏 > 商學院 > 國際經營管理英語碩士學程IMBA > 學位論文 > Item 140.119/118646

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题名:	產品L之藥品管理計畫執行-CG公司在台灣個案分析 Risk minimization measure implementation of product l in taiwan - case study of cg company
作者:	周明潔 Chou, Claire
贡献者:	張大為 Chang, David 周明潔 Chou, Claire
关键词:	產品 CG公司個案分析 Product CG Company Case Study
日期:	2018
上传时间:	2018-07-13 15:17:18 (UTC+8)
摘要:	The case study provides an analysis of the challenges and possible solutions of implementing risk minimization measures of Product L in Taiwan. X Company is an international biopharmaceutical company which based in New Jersey, USA. Product L is one of X Company’s major product for the multiple myeloma patients, a type of blood cancer that has the death rate of 70% within 5 years of diagnosis. Product L shows significant improvement in the treatment of multiple myeloma patients; however, its well-known risk of fetus malformation, i.e. phocomelia, caused a dramatic tragedy to thousands of mothers who used this drug as sedative back in 1950s due to lack of the concept of drug safety. To achieve the goal of ensuring patient safety on the medication use, the solutions are proposed with strategic imperatives. By reviewing the process and challenges on the actual operations, we could know what actions and resources are needed to deliver this objective, which is to execute the risk minimization measures smoothly so that all patients can receive the treatment without risk occurred in Taiwan. The recommendations are to keep having communication with Health authority and healthcare professionals as they are two major stakeholders in the risk minimization process implementation. Also, due to the unique healthcare system in Taiwan, X Company is willing to utilizing the advanced technology to help HCPs on diminishing the administrative work in the risk minimization process.
參考文獻:	[1] World Health Organization, http://apps.who.int/medicinedocs/en/ [2] Taiwan Food and Drug Administration, https://adr.fda.gov.tw [3] Ministry of Health and Welfare, https://www.mohw.gov.tw [4] Taiwan Multiple Myeloma Research Room, www.tmmrr.com [5] European Commission Press Release, http://europa.eu/rapid/press-release [6] The New England Journal of Medicine, https://www.nejm.org/ [7] Morningstar Inc., http://www.morningstar.com/ [8] US Food and Drug Administration, https://www.fda.gov/
描述:	碩士國立政治大學國際經營管理英語碩士學位學程(IMBA) 102933021
資料來源:	http://thesis.lib.nccu.edu.tw/record/#G0102933021
数据类型:	thesis
DOI:	10.6814/THE.NCCU.IMBA.020.2018.F08
显示于类别:	[國際經營管理英語碩士學程IMBA] 學位論文

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