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Program Code:
256
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
CHAIR
:
Kathleen Goin, MS (SCHNON), Associate Director, Clinical and Data Operations, Endo Pharmaceuticals Inc., United States
SPEAKER
(S):
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. For the past 5 years, as Co-founder of PharmaVigilant, she has been delivering technology to make the entire clinical development process faster, more efficient, and cost effective.
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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
Sherri Hubby has been involved in clinical research since 12/1998 when she began her career as an FDA investigator conducting inspections, heading up the auditing and management function and of several CROs and IRB. She joined Premier Research in 2008 as Director of Quality Assurance for the US.
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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.