校庆系列-校友学术讲座：汪燕（11.7）

主讲人：汪燕 博士（1980级，数学专业）

美国食品药品监督管理局

时间：11月7日 15:00-16:00

地点：必赢体育官网登录南校区旧数学楼104讲学室

题目：The Roles and Responsibilities of Statisticians at Center of Drug Evaluation and Research, FDA

摘要：

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA’s Center for Drug Evaluation and Research (CDER). To obtain marketing approval, drug manufacturers need to demonstrate the effectiveness and safety of their products through the conduct of adequate and well-controlled studies.  In this talk I will provide an overview of statisticians’ roles and responsibilities in the drug review process at the CDER, and illustrate some fundamental study design and statistical issues of randomized controlled clinical trials using examples of approved drugs.

校友简介：

Dr. Yan Wang is a statistical team leader in the Office of Biostatistics, Center of Drug Evaluation and Research at the U.S. FDA. She has been with FDA for 9+ years. In her current role, she leads and oversees the statistical reviews of investigational new drug, new drug application, and biologics license application submissions for the transplant and ophthalmology products. Her research interests include design of clinical trials, Bayesian methodology, and joint modeling analysis of longitudinal data and survival data.