临床试验支援与规范经理 - 成功大学.ppt

連絡方式 Email: hsing001@ / Deborah.Chiang@ Mobile: 0952 187173 * * * Legend Legend Legend Legend Legend Legend Legend Legend STICKER Legend Legend Legend Unit of measure * Footnote Source: Source Date Document Legend Legend Legend Legend Legend Legend Legend Legend STICKER Legend Legend Legend Unit of measure * Footnote Source: Source P4238 - US EMA Op Plan 臨床試驗 江斾萱 臨床試驗支援與規範經理 (Compliance Oversight Lead) 04 Oct 2013 簡介 什麼是臨床試驗 臨床試驗的過程 臨床試驗中的角色 臨床試驗與我們的關係 外界對臨床試驗及臨床試驗專員的迷思 英文要很好? 都要藥學系畢業? 臨床試驗專員賺很多? 臨床試驗報喜不報憂? 病人都是白老鼠? 我對臨床試驗的了解程度 簡介 1997-2001 高雄醫學大學 生物醫學暨環境生物學系 1997-2001 高雄醫學大學 生物醫學暨環境生物學系 2001-2003 國立成功大學醫學院 分子醫學研究所 2003-2006 國立陽明大學醫學院 生物藥學研究所 Pfizer Ltd 2006-2009 臨床試驗專員 2009-2010 資深臨床試驗專員 2010-2012 臨床試驗副理 2012-2013 臨床試驗支援與規範副理 2013- 臨床試驗支援與規範經理 美國藥品研究與制造商協會（PhRMA） Discovery Exploratory Development Full Development Registration Project Team and Plans Synthesis of Compounds Screening Studies in Healthy Volunteers (Phase I) Early Safety Studies Candidate Formulations Developed Extensive Safety Studies NDA / MAA Studies in 100-300 Patients (Phase II) Clinical Data Analysis Candidate Medicine Tested in 1000-5,000 Patients (Phase III) Large Amounts of Candidate Medicine Synthesized The Drug Development Process Study Manager Data Manager Clinician Clinical Research Associate (CRA) Project Manager Clinical Trial Associate Study team members: Sponsor 試驗計劃書 Clinician Statistician Development Survey from the database: which country to choose? Recommend by stakeholders Talk to each of the country for the feasibility 50 50 30 20 50 30 50 20 10 20 Quality Assurance Study manager Clinician Statistician Development Central Lab Data manager Supply Chain Clinical Operation Team 50 ? ? ? ? ? ? ? ? ? ? ? ? ? Clinical Study Protocol LOWEST LEVEL TERM (LLT) START DATE-FUL STOP DATE-FUL CTC AE GRADE-FUL AE ACTION Skin rash20081121 GRADE 2 STOPPED TEMP Hand and foot skin reaction20081120 GRADE 2 REDUCED Mucositis oral20081116 GRADE 2 STOPPE