課程說明
藥廠、受託研究機構之監管要求概述，以及與監管機構的溝通。跨部門之協商與合作、激勵措施如 FDA 優先審查券、專案管理、製造與分配、第四期上市後監測、藥物監測與上市後變更。
原文參考文本
Overview of regulatory requirements of pharmaceutical companies, contracting research organizations, and communication with regulatory agencies. Negotiation and collaboration between sectors, incentives such as FDA priority review vouchers, project management, manufacturing and distribution, phase IV post-marketing and continued monitoring, pharmacovigilance and post-marketing changes.
來源與參考
保留日期與來源以協助你核實資料。為便於閱讀提供譯文；官方來源為條件與要求的參照。
來源參考 : https://calendar.carleton.ca/grad/courses/HLTH/