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
Regards,
Constance
Burnett
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