You are here:
Vanderbilt Biostatistics Wiki
>
Main Web
>
Seminars
>
WednesdaySeminarSeries
>
LisaLaVangeJan272016
(25 Jan 2016,
AshleeBartley
)
(raw view)
E
dit
A
ttach
---++ Department of Biostatistics Seminar/Workshop Series ---+ *Statistics and Drug Regulations in the US* ---+ [[LisaLaVangeJan272016][Lisa M. LaVange, PhD]] <h4 align="left"><span style="color: #000000; font-size: 14px; line-height: 22px; background-color: transparent;">Office of Biostatistics, Office of Translational Sciences (OTS) </span></h4> <h5 align="left">%BLACK%Center for Drug Evaluation and Research (CDER)%ENDCOLOR%</h5> <h5 align="left"><span class="WYSIWYG_COLOR" style="color: black; font-size: 14px; line-height: 22px; background-color: transparent;">US FDA</span></h5> ---++++ <span style="color: #000000; font-size: 14px; line-height: 22px; background-color: transparent;">This talk will be a reflection on the importance of statistics in US drug regulation. I will look back to the early days of the FDA and describe the evolution of biostatistics as a discipline in the Center for Drug Evaluation and Research (CDER).</span> <span style="color: #000000; font-size: 14px; line-height: 22px; background-color: transparent;">The growth of biostatistics in size – from a single CDER division to an office of over 190 employees, and in mission – from a group focused on fundamental concepts of clinical trials to a group now engaged in numerous and varied aspects of drug development and both pre- and post-market regulation – will be briefly described. Moving to the present day, I will give a broad overview of the statistical issues and review challenges we face now, highlighting areas where statisticians make significant contributions through problem solving and effective leadership. Areas that hold opportunity for statisticians to provide innovation in drug regulation in the future will also be described.</span>
E
dit
|
A
ttach
|
P
rint version
|
H
istory
: r1
|
B
acklinks
|
V
iew topic
|
Edit
w
iki text
|
M
ore topic actions
Topic revision: r1 - 25 Jan 2016,
AshleeBartley
Main
Department Home Page
Biostatistics Graduate Program
Vanderbilt University Medical Center
Main Web
Main Web Home
Search
Recent Changes
Changes
Topic list
Biostatistics Webs
Archive
Main
Sandbox
System
Register
|
Log In
Copyright © 2013-2022 by the contributing authors. All material on this collaboration platform is the property of the contributing authors.
Ideas, requests, problems regarding Vanderbilt Biostatistics Wiki?
Send feedback