描述
制药公司、合同研究组织的监管要求概述以及与监管机构的沟通。部门间的谈判与合作、如 FDA 优先审评凭证等激励措施、项目管理、制造与分发、IV 期上市后和持续监测、药物警戒与上市后变更。
原文参考文本
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.
来源与参考
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来源参考 : https://calendar.carleton.ca/grad/courses/HLTH/