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 the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.