中英文ICH-Q8.ppt

PQS Management Responsibilities Expectations PQS管理职责与期望 Active sponsorship and communication across organization 积极发起和进行跨组织沟通 Establish quality policy 建立质量方针 Ensure quality is an attribute and not jut a function 保证质量是一个属性，而不仅仅是一个功能 Allocate resources and ensure PQS is appropriately prioritized 分配资源，并确保PQS得到适当优先 Active involvement in QSMR and other reviews 积极参与QSMR（质量体系管理审评）和其他审查 Establishing clear roles responsibilities 建立明确的角色和责任 Advocate continual improvement 倡导持续改进 * ICH Q8, Q9, Q10人用药物注册技术要求国际协调会议 Brenda Uratani, Ph.D. Assistant Country Director (Drugs