FDA/DIA Statistics Workshop 2011

FDA/DIA Statistics Forum 2011

Date(s) And Time(s):  Apr 11 2011 8:00AM - Apr 13 2011 3:35PM

Location:
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Statistics,Clinical Research,Professional Education, Training & Development,Clinical Safety/Pharmacovigilance,Medical Communications,Regulatory Affairs,Research & Development

Overview:
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 Identification
• Using CDISC/ADaM to Create Analysis-ready Datasets
• Collaborative Environments for Statistical Methodology Development
• Comparative Effectiveness 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

Learn more here.