DIA 2013 49th Annual Meeting
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First-in-Human Studies: How Much Complexity Is Too Much?
Track : Track 19: Communities Showcase
Program Code: 262
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 105
CHAIR :
 Royce A. Morrison, MD,MS (SCHNON), Executive Vice-Chair, Quorum Review, Inc., United States
SPEAKER (S):
Royce A. Morrison, MD,MS (SPKNON), Executive Vice-Chair, Quorum Review, Inc., United States
 Mary L Westrick, PhD (SPKNON), Vice President, US Phase I, Quintiles Inc., United States
 Stacie J. Bell, PhD (SPKNON), Director, Clinical and Translational Research, Questcor Pharmaceuticals, United States
William B. Smith, MD (SPKNON), Principal, New Orleans Center For Clinical Research, United States
Description
On the first-in-human (FIH) fast track, what defines "just right" design? Join us to hear experience of sponsor development teams, CROs, investigators and regulatory agencies, and best practice guidance on appropriate limits for FIH study complexity.

This session has been developed by the Clinical Pharmacology Community.