Hotel Information:
Hyatt Arlington
Course Location:
**Note Change**
Hyatt Arlington Hotel
1325 Wilson Boulevard
Arlington, VA 22209
Hotel rooms available at:
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA
Reservations: 800-233-1234 Direct #: 703-525-1234
Fax Number: (703) 908-4679
Discounted Hotel Room Rate: $184.00
Reserve Your Hotel Room:
call hotel and mention PERI discounted rate
Deadline to Receive Discounted Rate: 5/16/2006
Rate: $
184
Deadline for Group Rate:
2006-05-16
Hotel Policy
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Registration Rate:
$1,495.00 Register by 04/27/06
$1,695.00 Register after 04/27/06
Cancellation Date: 5/23/06 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
708-000-04-248-L03 (2.05 CEU)
Initial Release Date:
9/20/04
CBRN:
N/A
CME:
20.50 Hours of Category 1 Credit
VNA:
04-04-05 24.60 Contact Hours
Continuing Education Policy
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Course Description:
View the Agenda
This course provides an overview of the role of the statistician in clinical development. It is designed for statisticians new to the pharmaceutical industry as well as other research team members interested in learning more about statistical issues in drug development. Specific topics include developing clinical plans, understanding FDA/ICH guidelines as well as the role of FDA statistical reviewers, developing protocols and analysis plans, assessing safety and efficacy, conducting interim analyses, and developing requirements for an analysis-ready database. The faculty, which includes statisticians from industry as well as the FDA, delivers information and shares their experiences using a combination of interactive sessions and workshops where participants will gain hands-on experience in developing a protocol and analysis plan.
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Who Should Attend:
This course is designed for new clinical statisticians and other members of the clinical research team. The course is recommended for statisticians with less than 2 years but at least 6 months of experience in the pharmaceutical industry.
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Educational Objectives:
Upon completion of this course, participants should be able to:
- Recognize FDA/ICH requirements and the role of the FDA in the IND/NDA statistical review process
- Describe statistical issues involved with protocol and statistical analysis plan development
- Define the statistician's role as a consultant and some of the special challenges this role implies
- Identify the steps needed to develop an analysis-ready database
- Discuss issues involved in conducting interim analyses of clinical trials
- Apply statistical techniques for assessing drug safety
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Key Topics:
- The Role of the Clinical Statistician
- The Development and Execution of a Clinical Program
- Regulatory Requirements for Drug Development
- Analysis of Efficacy
- Interim Analysis and Data Monitoring Committee Process
- Development of a Clinical Study Protocol
- Data Management Considerations in Clinical Trials
- Assessment of Safety in Clinical Trials
- Planning and Reporting Your Analysis
- Clinical Program Development Workshop
- The Statistician as a Consultant
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Course Director(s):
Eileen B. Brown, PhD
Senior Statistician
Eli Lilly & Company
Naitee Ting, PhD
Course Co-Director
Associate Director
Biostatistics
Pfizer Global Research & Development
Scott R. Evans, Ph.D. M.S.
Research Scientist
Department of Biostatistics
Harvard University
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Contact Course Manager:
Course Manager
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PERI reserves the right to change agenda
items and instructors without notice to accommodate
situations beyond its control.
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