Drug Information Association (DIA)and Food and Drug Administration (FDA) to Host 3rd Annual Statis...( Speakers fro...),Health

Date:3/17/2009

Speakers from the FDA Center for Drug Evaluation and Research (CDER), industry, and academia will convene at the Drug Information Association's (DIA's) 3rd Annual Statistics Forum (April 26-29; Arlington, VA) to discuss statistical methodologies and quantitative approaches in the development and review of therapeutic drugs and biologics.

Horsham, PA (Vocus) March 17, 2009 -- Speakers from the FDA Center for Drug Evaluation and Research (CDER), industry, and academia will convene at the Drug Information Association's (DIA's) 3rd Annual Statistics Forum (April 26-29; Arlington, VA) to discuss statistical methodologies and quantitative approaches in the development and review of therapeutic drugs and biologics.

Featured topics will include:

• Biomarkers
• New directions and guidance for safety planning and reporting
• CDISC
• Follow-up on FDA Guidances: Adaptive design; Non-inferiority; Missing data; Multiplicity

"The annual FDA/DIA Statistics Forum provides an open forum to discuss the statistical and regulatory implications of FDA initiatives and Guidances," explains Program Co-chair Barry Schwab, PhD, Vice President, Clinical Biostatistics, Johnson & Johnson Pharmaceutical Research and Development, LLC. "Statisticians, clinicians and other industry, academia, CRO and agency personnel come together to share in
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