报告的题目是：Update on CDER’s Novel Drug Approvals and Priorities

            FDA药品评估研究中心（CDER）新药审评和工作重点

报告时间：3月14日（周一）上午10：00

报告地点：实验十八楼315会议室 

报告人：古丽主任，FDA驻华办主任

附件是古丽主任的个人简介：

Dr. Verbois will begin by providing an overview of FDA and CDER.  This overview will focus on the   organizational structure of the Agency and will highlight the role organizations play in pharmaceutical quality.   Given restructuring of the Center for Drug Evaluation and Research, an explanation of recent changes will be provided.  The presentation will go on to highlight the role that expedited review pathways, including Breakthrough Therapy Designation, have played in ensuring that therapeutically important drugs are approved and available to patients at an earlier time.  Dr. Verbois will conclude her presentation describing CDER priorities for the coming year.

古丽博士将首先介绍FDA和药品评估研究中心（CDER）的总体情况，重点是FDA的组织框架，明确其中跟药品质量相关部门的职责。由于药品评估研究中心最近进行了重组，她还会介绍CDER的这些变化。报告会重点介绍包括突破治疗在内的加速审评的途径，这些途径将确保重要的治疗药物得到批准并尽早为病人所用。古丽博士最后还会介绍CDER在近几年的工作重点。

古丽主任先做1小时的报告，然后和其他同事们一起回答问题。