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Bethesda North Marriott Hotel and Conference Center

Apr 20, 2015 8:30 AM - Apr 22, 2015 4:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics 2015 Forum

Overview

Tutorials: April 19, 2015

Now in its ninth year, the DIA/FDA Statistic 2015 Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique Forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives.

You will have the opportunity to focus on statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the pre- and postmarket settings.

Featured topics

  • Biosimilars/Analytical Similarity
  • Adaptive Design and Bayesian Working Group Feedback
  • Sentinel Initiative and Postmarketing Surveillance
  • Statistical Issues Related to Health Technology Assessment
  • Subgroup Analysis
  • Benefit-Risk
  • Estimands and Sensitivity Analyses
  • FDA and Industry Town Hall

Featured

Want to learn more about DIA/FDA Statistics 2015 Forum? You've come to the right site!

Continuing-Education

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Who should attend?

  • Statisticians
  • Clinicians
  • Epidemiologists
  • Pharmacometricians
  • Drug Safety Professionals
  • Regulatory and Medical Communication Scientists

Learning objectives

At the conclusion of this meeting, participants should be able to:

  • Recognize innovative statistical solutions to issues associated with the evidence and regulatory review of medical products
  • Describe the application of statistical methodologies and thinking to the development of new medical products
  • Assess the impact of regulations and guidance on statistical practice
  • Discuss ideas for improving the communication between industry Statisticians and Reviewers

Program Committee

  • Ram Tiwari, PhD, MS
    Ram Tiwari, PhD, MS Head of Statistical Methodology
    Bristol Myres Squibb , United States
  • Joan Buenconsejo, PhD, MPH
    Joan Buenconsejo, PhD, MPH Head of Cardiovascular and Neuroscience Biostatistics
    Bristol Myers Squibb, United States
  • Frank Bretz, PhD
    Frank Bretz, PhD Distinguished Quantitative Research Scientist
    Novartis , Switzerland
  • Brenda Crowe, PhD
    Brenda Crowe, PhD Associate Vice President, Statistics
    Eli Lilly and Company, United States
  • Jeff Maca, PhD
    Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
    Quintiles, United States
  • Laura J. Meyerson, PhD, MA
    Laura J. Meyerson, PhD, MA Vice President, Biostatistics
    Biogen Idec, United States
  • Walter Offen, PhD
    Walter Offen, PhD Global Head of Statistical Innovation & Safety Statistics
    AbbVie Inc, United States
  • Estelle Russek-Cohen, PhD
    Estelle Russek-Cohen, PhD Senior Advisor, Office of Biostat
    FDA, United States
  • Jerald Schindler, DrPH
    Jerald Schindler, DrPH Chief Executive Officer
    Strategic Statistics, United States
  • Steve Wilson, PhD
    Steve Wilson, PhD Senior Staff Fellow, OB, OTS, CDER
    FDA, United States
  • Peiling Yang, PhD
    Peiling Yang, PhD Supervisory Mathematical Statistician
    FDA, United States
  • Lisa LaVange, PhD
    Lisa LaVange, PhD Professor Emerita
    University of North Carolina at Chapel Hill, United States

Digital Learning Catalog

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