Tuesday, February 5, 2013

PDUFA V Statistical Topics and Emerging New Issues

Call for Posters and Roundtable Luncheon Topics Deadlines Extended
This year’s theme is PDUFA V Statistical Topics and Emerging New Issues. Now in its seventh year, this unique forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives including PDUFA V initiatives, as well as 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 post-market settings. Over the three days, in-depth discussions on key topics relevant to the evaluation of therapeutic products will take place, and include input from key thought leaders from regulatory agencies, industry, and academia.
With the success of last year’s forum we will continue to offer additional avenues for interaction and scientific discourse via a scientific poster session during the networking reception and an interactive round-table luncheon event.
Call for Posters Submission Deadline: February 28
Call for Roundtable Luncheon Topics Submission Deadline: February 28
Please Note: DIA User ID and Password is needed to submit an abstract. Did you land on the My DIA Page? If so, please select “My Abstract Submissions” on the left side to submit an abstract.
Keynote Speaker:
Monday, April 29
Robert N. Rodriguez, PhD
Past President, American Statistical Association
Senior Director, Statistical Research and Development
SAS Institute
Session Topics:
• PDUFA V Overview
• Statisticians as Leaders
• FDA Upcoming Guidance Update (Multiplicity and Enriched Populations)
• Dichotomizing Continuous Measures for a Primary Efficacy Endpoint –
Weighing the Benefits and Risks
• Measures for Primary Efficacy Endpoint – Are we Substantially Compromising
Statistical Power?
• Pre-Competitive Collaboration
• Meta Analysis for Safety Data
• Companion Diagnostics
• (Premarketing) Benefit-Risk Assessment in Clinical Development and
Regulatory Review
• (Premarketing) Benefit-Risk Assessments
• Health Technology Assessment and Comparative Effectiveness Research:
Their Impact on Access to Pharmaceutical Products and Their Role in Designing
Product Development Strategies
• Missing Data: When is it Important to Collect Data After Study Drug Discontinuation?
• Missing Data: Case Study Presentation and Panel Discussion
• Overview and Commentary of FDA Guidances: Multiplicity and/or Enriched Populations
Tutorial Topics:
Statistical Methods for Safety Surveillance
Missing Data in Clinical Trials
Benefit-Risk Evaluation

We look forward to seeing you in April!
Constance Burnett
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