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Date(s) And Time(s):
Mar 10 2011 8:00AM - Mar 11 2011 4:00PM

Location:
Double Tree Hotel and Executive Meeting Center
8120 Wisconsin Avenue
Bethesda, MD 20814

KEYNOTE SPEAKER
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)

Discuss Major Themes and Best Practices in Regulatory Information Synthesis of Randomized
Trials for Product Safety Evaluation.

Regulators and sponsors need to continually assess the risk-benefit of medical
products throughout the life-cycle. When a safety issue is identified in a development
program the issue is addressed prospectively in the program safety
analysis plan with a goal to combine the data across studies. In the absence
of large-scale confirmatory studies on the safety of products it is necessary to
synthesize the available scientific evidence. A regulatory information synthesis
(RIS) includes the systematic review and a meta-analysis, if appropriate
to combine data across studies. Guidance on best practices for RIS enhances
transparency, objectivity, reproducibility, consistency and interpretation. RIS is
an important tool in safety evaluation and is one of several sources of evidence
that is considered in support of risk-benefit decisions in the regulatory setting.
Those who have suggestions or comments regarding this topic may
communicate via E-mail to: meta-analysis_guidance@fda.hhs.gov

FEATURED TOPICS
• Best Practices for Information Synthesis
• Format and Content of a Protocol for Safety Information Synthesis
• Minimizing Bias in Information Synthesis
• Dealing with Heterogeneity
• Analytical Considerations for Sparse Data
• Bayesian and Frequentist Analytical Strategies
• Meta-analysis of a Class of Products

Target Audience:
Professionals involved in:
• Biostatistics
• Clinical research
• Compliance
• Data analysis
• Drug Safety and
Pharmacovigilance
• Epidemiology
• Labeling
• Medical Information
• Quality assurance/Quality control
• Regulatory aff airs
• Risk management

Event Code:
11011

Contact Constance Burnett at the DIA offi ce by telephone
215.293-5800, fax 215.442.6199 or email Constance.Burnett@diahome.org.