DIA 2013 49th Annual Meeting
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GCP Risk-based Monitoring
Track : Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code: 256
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 156AB
CHAIR :
Kathleen Goin, MS (SCHNON), Associate Director, Clinical and Data Operations, Endo Pharmaceuticals Inc., United States
SPEAKER (S):
 Penelope K. Manasco, MD,MS (SPKNON), CEO, MANA Consulting, United States
Kathleen Goin, MS (SPKNON), Associate Director, Clinical and Data Operations, Endo Pharmaceuticals Inc., United States
 Sherri A. Hubby, (SCHNON), Director, US Quality Assurance, Premier Research Group, United States
Description
This symposium will discuss the impact of the FDA "Guidance for Industry Oversight of Clinical Investigations," explore how a study team implemented some risk-based strategies and examine various strategies to implement risk-based monitoring strategies to enhance site and monitor performance in the conduct of clinical trials.