FDA Workshop To Bring Statisticians in
Industry and Academia Together
Ning Li, FDA, and Jeffrey Maca, Novartis Pharmaceuticals
The short courses include Biomarkers in
Based on continued positive feedback
Risk Prediction by Margaret Pepe, Multiple
from previous attendees, luncheon roundta-
testing Problems in Pharmaceutical Statistics
bles—with moderated discussion on a vari-
by Alex Dmitrienko, Statistical Graphics
ety of topics—will take place on Tuesday,
by Frank Harrell, Meta-analysis of Clincial
September 16.
Trials by Anne Whitehead, and Clinical
The Marriott Crystal Gateway is a pre-
Trial Adaptive Design by James Hung and
mier meeting site located minutes from
Sue-Jane Wang. Due to the continuing
downtown Washington, DC, and Reagan
T
he 12th FDA/Industry Statistics
popularity of the workshop, an increased
National Airport. It offers a full suite of ame-
Workshop is scheduled for September
number of concurrent sessions on a variety
nities and services, including direct access to
15–17 at the Marriott Crystal Gateway
of topics will be offered, including Effective
the Metro from the lobby. A block of sleep-
in Arlington, Virginia. Short courses are sched-
Communication between FDA and Industry
ing rooms has been arranged for workshop
uled for the first day, September 15, followed
Statisticians; Adaptive Designs; Clinical Trial
attendees. To receive the special workshop
by two days of sessions about the science and
Strategies; Issues in Developing Guidance for
rates, attendees must book their reserva-
statistics associated with the development of
Noninferiority Trials; Safety Risk Assessments
tions by August 26. Visit www.amstat.org/
medical products (pharmaceuticals, biologics,
and Risk Minimization Action Plans; Vaccine
meetings/fdaworkshop for additional hotel
and devices). Sponsored by the
Trials, Monitoring, Diagnostic Imaging
information, the preliminary program, a list
Biopharmaceutical Section of the American
and In Vitro Diagnostics; Challenges and
of workshop organizers, online registration,
Statistical Association, with cooperation from
Developments in Sample Size Re-estimation;
or the PDF registration form.
the Food and Drug Administration, the work-
CMC Issues in Biologicals and Biotechnology
The FDA/Industry Statistics workshop
shop will bring together statisticians from
Products; and Statistical and Regulatory Issues
is a unique forum for statisticians to dis-
industry, academia, and the FDA, as well as
for the Companion Diagnostic in Drug-
cus topics of mutual interest. The orga-
provide a unique opportunity for open dia-
Diagnostic Combinations.
nizing committee looks forward to seeing
logue on issues of mutual interest.
you in September! n
BAps - Beyond Ap statistics: A Workshop for experienced teachers
August 5, 2008, 8:30 a.m.–4:30 p.m.
The ASA/NCTM Joint Committee on Curriculum in Statistics and Probability is pleased to sponsor a Beyond AP Statistics
(BAPS) workshop during the annual Joint Statistical Meetings in Denver on August 5, 2008. The BAPS workshop is offered for
AP Statistics teachers and consists of enrichment materials just beyond the basic AP syllabus.
The course fee for the full day is $50. Lunch will be provided. Please note that course attendees do not have to register
for the Joint Statistical Meetings to participate in this workshop.
fOrMAt: The course is divided into four sessions, led by noted statisticians who will present on the following topics:
Roxy Peck—Logistic Regression, CalPoly, San Luis Obispo
W. Robert Stephenson—Experimental Design: To Block or Not To Block? Iowa State University
Tom Short—Bootstrap Methods, Indiana University of Pennsylvania
Stephen M. Miller—Topics in Survey Methodology Bureau of Labor Statistics, Joint Program in Survey Methodology,
University of Maryland
reGistrAtiON: To register online or print out a registration form, visit www.amstat.org/education/baps.
lOCAtiON: Metro State College of Denver, SI Building, Auraria Campus, 1150 12th St., Denver, C0 80204
QuestiONs: Contact Rebecca Nichols, ASA assistant director of K–16 education programs, at rebecca@amstat.org or
(703) 684-1221, Ext. 1877.
20 AMSTAT NEWS JUNE 2008
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