Presented by the UCI Center for Statistical Consulting
Co-sponsored by
the UCI Office of Research and Graduate Studies & the UCI College of Medicine Wednesday, February 4, 1998
Speaker Peter A. Lachenbruch, PhD
Biostatistics Branch Chief
Division Biostatistics and Epidemiology
Center for Biologics Evaluation & Research
Food & Drug Administration
U.S. Department of Health & Human Services
Title Some Observations on Statistical Reviewing at the FDA
Abstract
This presentation will be comprised of two related topics:
The first part of the talk will address the principles used by the FDA
when reviewing pre-licensure and licensure applications.
The second part of the talk will identify statistical knowledge that is
helpful/necessary for statisticians in the pharmaceutical industry or in
a regulatory agency such as the FDA. While no one statistician can be expected
to know all of the topics identified, all of the topics do come to bear
on some applications
Click here for an expanded list of topics:
Part 1,
Part 2
Schedule 4:15 pm: Reception (coffee/cookies) 5:00 pm: Presentation begins Location
The Nelson Auditorium, in Irvine Hall (Bldg #835)
at the College of Medicine, on the main campus of UCI
Parking in Lot 83 ($4.00 for visitors) Freeway Map to UCI
Campus map showing Irvine Hall (835)
For further information about this event
Please contact the UCI Center for Statistical Consulting
by telephone: [949] 824-1680 or by e-mail:
stats@uci.edu