DIA 48th Annual Meeting
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Building Quality into Clinical Trials: Regulatory Perspectives and Practical Considerations
Track
:
Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code:
167
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Winifred Ann Meeker-O'Connell, FDA, United States
PRESENTER
(S):
Fergus Sweeney, European Medicines Agency, United Kingdom Kenneth Sprenger, Pfizer Inc, United States Winifred Ann Meeker-O'Connell, FDA, United States
Description
Current models for clinical trial oversight have become outmoded in a global, complex environment. This session describes recent efforts to foster new models that employ risk-based approaches and that build quality into clinical trials.
Learning Objectives:
Describe risk-based approaches that build quality into clinical trials
Discuss how monitoring fits within an overall, risk-based quality framework
Describe possible approaches for applying quality-by-design and quality risk management principles to clinical trials.
Learning Objectives:
Describe risk-based approaches that build quality into clinical trials
Discuss how monitoring fits within an overall, risk-based quality framework
Describe possible approaches for applying quality-by-design and quality risk management principles to clinical trials.
This session is a part of:
Handout Online
