DIA/FDA Statistics Forum 2011 Advances Regulatory Science

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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.

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The DIA/FDA Statistics Forum provides a unique opportunity to learn about and discuss emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.

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.

Register for FDA/DIA Statistics Forum 2011.

ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. 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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