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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

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
    Ram Tiwari, PhD Director, Division of Clinical Evidence and Analyses 2, Biostatistics, CDRH
    FDA, United States
  • Joan  Buenconsejo, PhD, MPH
    Joan Buenconsejo, PhD, MPH Director and Biometrics Team Leader
    AstraZeneca, United States
  • Frank  Bretz, PhD
    Frank Bretz, PhD Global Head of Statistical Methodology and Consulting Group
    Novartis Pharma AG, Switzerland
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    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 S. Schindler, DrPH
    Jerald S. Schindler, DrPH Vice President
    Alkermes, Inc., United States
  • Stephen E. Wilson
    Stephen E. Wilson Senior Staff Fellow
    FDA, United States
  • Peiling  Yang, PhD
    Peiling Yang, PhD Statistics Team Lead, Division Biometrics I, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Lisa M. LaVange, PhD
    Lisa M. LaVange, PhD Professor and Associate Chair, Department of Biostatistics
    University of North Carolina at Chapel Hill , United States
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Contact us

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Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details and Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442. 6149
Fax +1.215.442.6199
Stephanie.Ritter@diahome.org

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