Date(s) And Time(s):
Apr 10 2011 8:00AM - Apr 13 2011 4:00PM
Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...
An Open Forum to Discuss Important Statistical Issues Associated with the Development and Review
of Therapeutic Drugs and Biologics.
Don’t miss your annual opportunity to learn about and discuss the current and
emerging statistical methodologies and quantitative approaches used to develop
evidence of the efficacy and safety of new drug and biologic therapeutic
products.
Now in its fifth year, this year’s meeting will continue the dialogue in an open,
public forum, regarding FDA guidance development and regulatory science
initiatives — emphasizing the statistical challenges associated with innovative
approaches to the design and analysis of clinical trials data.
In recent years, thought leaders from government agencies, industry, and academia have discussed:
• Meta-analysis in the Evaluation of Cardiovascular Risk
• FDA Guidance Documents on Non-inferiority and Adaptive Designs
• Modeling and Simulation for Quantitative Decision Making
• Challenges in Developing Tailored Therapies by Subgroup Identifi cation
• Using CDISC/ADaM to Create Analysis-ready Datasets
• Collaborative Environments for Statistical Methodology Development
• Comparative Eff ectiveness Research
• Biomarker Development and Assessment
• Previous Year’s Statistical and Regulatory Highlights
Learning Objectives:
At the conclusion of this conference, participants should be able to:
Explore and implement innovative statistical solutions to issues associated with the evidence and regulatory review of therapeutic drugs and biologics
Describe the application of statistical methodologies and thinking to the development of new therapeutic biologics and drugs
Assess the impact of regulations and guidance on statistical practice
Discuss ideas for improving the communication between Industry Statisticians and Reviewers
Target Audience:
Statisticians
• Clinicians
• Epidemiologists
• Drug safety professionals
• Regulatory and medical communication scientists
Event Code:
11008
Contact Information:
Conference: JoAnn Boileau, Program Manager
Phone 215.442.6175
Fax 215.442.6199
email JoAnn.Boileau@diahome.org