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DIA and FDA Statistics Forum 2011 Advances Regulatory Science

Horsham, PA, USA — Mar 08, 2011

DIA and FDA will co-host FDA/DIA Statistics Forum 2011 from April 10-13 in Bethesda, MD.

Now in its fifth year, this year’s workshop will continue the dialogue on FDA guidance development and regulatory science initiatives, with particular emphasis on the statistical challenges associated with innovative approaches to the design and analysis of clinical trials data. Thought leaders from government agencies, industry, and academia will be on hand to lead sessions, including:

  • Report from the NAS Panel on Missing Data: Overview and Recommendations
  • Feedback and Comments on the NAS Missing Data Panel Report: Regulatory and Industry Views
  • Panel Discussion on the NAS Missing Data Panel Report
  • Bayesian Applications in the Device Industry, CDRH
  • Guidance, and Bayesian Approaches
  • Bayesian Applications in the Pharmaceutical and Biotech Industries
  • Data Monitoring Committee Experiences in Multi-regional Clinical Trials
  • Meta-Analysis: Efficacy and Safety
  • Risk and Benefit Assessment Approaches
  • Clinical Case Studies

“The DIA/FDA Statistics Forum provides a unique opportunity to learn about and discuss the current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products,” says Program Co-chair Dr. Barry Schwab, Vice President, Clinical Biostatistics, Johnson & Johnson Pharmaceutical Research and Development, LLC.

 

 

 

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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.