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DIA 2013 49th Annual Meeting
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Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians
Track : Track 15: Statistical Science and Quantitative Thinking
Program Code: 320
Date: Wednesday, June 26, 2013
Time: 8:00 AM to 9:30 AM  EST
Location: 157AB
CHAIR :
 Susan P. Duke, MS (SCHNON), Manager, Benefit/Risk Evaluation, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, United States
SPEAKER (S):
 Conny Berlin, MS (SPKNON), Global Head, Quantitative Safety Function, Novartis Pharma AG, Switzerland
 Jonathan D. Norton, MS (SPKNON), Mathematical Statistician, Division of Biometrics V, OB, OTS, CDER, FDA, United States
 Scott Evans, PhD (SPKSUP), Senior Research Scientist, Harvard University School of Public Health, United States
Description
Benefit-risk in clinical development is increasingly important to statisticians, as interest from regulators in more formal methods increases. We will describe decision science and statistical approaches, and what more statisticians can do in this area.

Session Recording
(Code: 320)
DIA 2013 Attendee:
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This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
Handout Online
(Code: 320)
DIA 2013 Attendee:
Attendees Login
  
This session is a part of:
DIA 2013 Live Learning Center
CON4 Comp Access: Wednesday Online Access Package - June 26, 2013
Quantitative Benefit-risk in the Current Regulatory Environment and the Implications for Clinical Statisticians