| dc.contributor.advisor | 張大為 | zh_TW |
| dc.contributor.advisor | Chang, David | en_US |
| dc.contributor.author (Authors) | 周明潔 | zh_TW |
| dc.contributor.author (Authors) | Chou, Claire | en_US |
| dc.creator (作者) | 周明潔 | zh_TW |
| dc.creator (作者) | Chou, Claire | en_US |
| dc.date (日期) | 2018 | en_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) | G0102933021 | en_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) | 102933021 | zh_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 12. Company Profile 52.1. Company Background 52.2. Business Scope 72.3. X Company structure in Taiwan 83. Risk Management Plan Overview 103.1. Risk Management Plan 103.2. Background: the story of Risk Minimization Measures of Product L 123.3. Overview of Product L’s risk minimization measures 133.4. The Safety Profile of Product L 154. Market Overview 184.1. Taiwan blood cancer market overview 184.2. Treatment overview 194.3. X Company blood cancer treatment products 215. Risk Minimization Measures Implementation Strategy 255.1. Global Strategy 255.2. Local Strategy 275.3. The challenges of risk minimization implementation in Taiwan 316. Conclusion and Recommendation 387. Reference 43 | zh_TW |
| dc.source.uri (資料來源) | http://thesis.lib.nccu.edu.tw/record/#G0102933021 | en_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) | Product | en_US |
| dc.subject (關鍵詞) | CG Company | en_US |
| dc.subject (關鍵詞) | Case Study | en_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 company | en_US |
| dc.type (資料類型) | thesis | en_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 | - |
