概览

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.

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Continuing-Education

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Continuing-Education

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学习目标

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

项目委员会

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