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Office of
Pharmacoepidemiology and Statistical Science
Welcome
Welcome to the Office of Pharmacoepidemiology and Statistical Science (OPaSS).
OPaSS plays a significant role in the Center’s mission of assuring the
availability of safe and effective drugs for the American people by:
- Providing leadership, direction, planning, and policy formulation for CDER’s
risk assessment, risk management, and risk communication programs;
- Working closely with the staff of CDER's other
"super" offices, the Office of New Drugs and the Office of
Pharmaceutical Science, to provide the statistical and computational aspects of drug review evaluation and research.
Who We Are
OPaSS, which includes the Office of
Biostatistics and the Office of Drug
Safety, was created as part of a 2002 CDER reorganization and has
about 180 of CDER’s 1,700 employees. Staff working in the Office of
Biostatistics and the Office of Drug Safety have
backgrounds in a variety of disciplines including medicine, epidemiology, pharmacology, pharmacy,
statistics, regulatory science, health science, information technology,
and administration and support services.
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- Our strategic plan describes the mission,
vision, operating principles, goals, research agenda, and risk
communication strategy for OPaSS and its direct operating units.
We expect to post a copy of this document on this web site soon.
- Special Initiatives:
Presentations
2005
- DIA Annual Office of Drug Safety Update, Paul
J. Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Assessing Drug Safety, Paul J. Seligman,
M.D., M.P.H., FDA. [PPT]
or [PDF]
- Topics in Drug Safety, Jonca Bull, M.D., FDA.
[PPT] or [PDF]
- Post-Market Drug Safety, Paul J. Seligman,
M.D., M.P.H., FDA. [PPT]
or [PDF]
- Post-Market Drug Safety: Current Initiatives &
Future Directions, Paul J. Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Data Mining: Status of FDA’s Efforts, Paul J.
Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Risk Management Guidances Training, Paul J.
Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Challenges of Communicating Risks, Paul J.
Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Labeling Prescription Drugs for Physicians and
Consumers (FDA Perspective), Paul J. Seligman, M.D., M.P.H.,
FDA. [PPT]
or [PDF]
- Epidemiology Panel Discussion: Postmarketing
Safety Review in CDER, Paul J. Seligman, M.D., M.P.H., FDA. [PPT]
or [PDF]
- Pharmacovigilance Working Group: Potential Future
ICH Topics Update, International Conference on Harmonisation
Brussels, Belgium [PPT]
or [PDF]
Presentations
2001-2004
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Other Resources
- Medical
Errors and Patient Safety. From the Agency for Healthcare Research and Quality,
this web page provides links to resources for healthcare providers,
policymakers, and patients to help reduce medical errors and improve
patient safety.
- Patient Safety Task Force Fact Sheet.
The Patient Safety Task Force was established within the Agency for Healthcare Research and Quality
to coordinate integrating data collection on medical errors and adverse
events, coordinate research and analysis efforts, and promote
collaboration on reducing the occurrence of injuries that result from
medical errors.
- The National Children’s Study.
The National Children’s Study, sponsored in part by the
Department of Health and Human Services, examines the effects of
environmental influences on the health and development of more than
100,000 children across the United States.
- Quality Interagency Coordination
(QuIC) Task Force. The Task Force goals are to reduce the
underlying causes of illness, injury, and disability, reduce health care
errors, and increase patient participation in their own care.
- The Centers for
Education and Research on Therapeutics (CERTS). (CERTs)
is a research program administered by the Agency
for Healthcare Research and Quality. The mission of the CERTs is
to conduct research and provide education that will advance the optimal
use of drugs, medical devices, and biological products.
Contact Us
Please e-mail us at webmaster@cder.fda.gov
with feedback about this site.
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Date created: January 31, 2006; Last updated: May, 2, 2006 |
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