The Drug Information Association (DIA) and the US FDA will host the 4th Annual FDA/DIA Statistics Forum: Integrating Knowledge in Clinical Development from April 19-21 in Bethesda, MD.

Statisticians, clinicians and other professionals from industry, academia, CROs, and government agencies, will have an opportunity to learn about and assess current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products. Participants will also have a unique opportunity to examine their roles in this enterprise and ask questions to develop appropriate, scientific/regulatory consensus regarding our purpose and process in the areas of:

• Meta-Analysis to Evaluate Cardiovascular Risks

• FDA Guidance on Non-Inferiority

• Issues Associated with Meta-Analysis for Margin Justification

• Modeling and Simulation for Quantitative Decision Making in Drug Development

• Challenges in Developing Tailored Therapies by Subgroup Identification

• Using CDISC/ADaM to Create Analysis-ready Datasets

• Collaborative Environments for Statistical Methodology Development—The Wiki Way

• Comparative Effectiveness Research

Register for 4th FDA/DIA Statistics Forum.

ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 biotechnology, pharmaceutical, academic, and regulatory professionals. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.

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Contact: Joe Krasowski
DIA
215-293-5812
Joe.Krasowski@diahome.org