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題名 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
貢獻者 張大為
Chang, David
周明潔
Chou, Claire
關鍵詞 產品
CG公司
個案分析
Product
CG Company
Case Study
日期 2018
上傳時間 13-Jul-2018 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
資料類型 thesis
dc.contributor.advisor 張大為zh_TW
dc.contributor.advisor Chang, Daviden_US
dc.contributor.author (Authors) 周明潔zh_TW
dc.contributor.author (Authors) Chou, Claireen_US
dc.creator (作者) 周明潔zh_TW
dc.creator (作者) Chou, Claireen_US
dc.date (日期) 2018en_US
dc.date.accessioned 13-Jul-2018 15:17:18 (UTC+8)-
dc.date.available 13-Jul-2018 15:17:18 (UTC+8)-
dc.date.issued (上傳時間) 13-Jul-2018 15:17:18 (UTC+8)-
dc.identifier (Other Identifiers) G0102933021en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/118646-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 國際經營管理英語碩士學位學程(IMBA)zh_TW
dc.description (描述) 102933021zh_TW
dc.description.abstract (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.
en_US
dc.description.tableofcontents 1. Introduction 1
2. Company Profile 5
2.1. Company Background 5
2.2. Business Scope 7
2.3. X Company structure in Taiwan 8
3. Risk Management Plan Overview 10
3.1. Risk Management Plan 10
3.2. Background: the story of Risk Minimization Measures of Product L 12
3.3. Overview of Product L’s risk minimization measures 13
3.4. The Safety Profile of Product L 15
4. Market Overview 18
4.1. Taiwan blood cancer market overview 18
4.2. Treatment overview 19
4.3. X Company blood cancer treatment products 21
5. Risk Minimization Measures Implementation Strategy 25
5.1. Global Strategy 25
5.2. Local Strategy 27
5.3. The challenges of risk minimization implementation in Taiwan 31
6. Conclusion and Recommendation 38
7. Reference 43
zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0102933021en_US
dc.subject (關鍵詞) 產品zh_TW
dc.subject (關鍵詞) CG公司zh_TW
dc.subject (關鍵詞) 個案分析zh_TW
dc.subject (關鍵詞) Producten_US
dc.subject (關鍵詞) CG Companyen_US
dc.subject (關鍵詞) Case Studyen_US
dc.title (題名) 產品L之藥品管理計畫執行-CG公司在台灣個案分析zh_TW
dc.title (題名) Risk minimization measure implementation of product l in taiwan - case study of cg companyen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (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/
zh_TW
dc.identifier.doi (DOI) 10.6814/THE.NCCU.IMBA.020.2018.F08-