Event Date/Time: Apr 23, 2012
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Description

Learn About and Discuss the Current and
Emerging Statistical Methodologies and Quantitative Approaches
Now in its sixth year, this unique workshop continues the dialogue on issues including FDA guidance development and regulatory science initiatives. The dialogue will focus on statistical opportunities and challenges associated with innovative approaches to design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the postmarket setting.
The Forum offers in-depth discussions on key topics relevant to the evaluation of therapeutic products and includes input from key thought leaders from regulatory agencies, industry, and academia.
In recent years, thought leaders have discussed:
• Handling Missing Data in Clinical Trials
• Bayesian Applications in the Device, Pharma and Biotech Industries
• Meta-Analysis for Safety and Efficacy
• FDA Guidance Documents on Non-inferiority and Adaptive Design
• Modeling and Simulation for Quantitative Decision Making
• Challenges in Developing Tailored Therapies
• Comparative Effectiveness Research
• Biomarker Development and Assessment
• Previous Year’s Statistical and Regulatory Highlights
WHO SHOULD ATTEND
• Statisticians
• Clinicians
• Epidemiologists
• Drug safety professionals
• Regulatory and medical communication scientists
LEARNING OBJECTIVES:
At the conclusion of this conference participants should be able to:
• Recognize innovative statistical solutions to issues associated with the evidence and regulatory review of medical products
• Describe the application of statistical methodologies and thinking to the development of new medical products
• Explain the impact of regulations and guidance on statistical practice
• Discuss ideas for improving the communication between industry statisticians and reviewers

Venue

Additional Information

Please monitor the DIA website for Continuing Education information. This program has been developed by the FDA and the DIA Statistics Special Interest Area Community (SIAC).