DIA 48th Annual Meeting
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Quality by Design: Is Your Clinical Trial Fit for Purpose?
Track
:
Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code:
140
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Regina Freunscht, Accovion GmbH, Germany
PRESENTER
(S):
Jean Mulinde, FDA, United States James Huang, Forest Research Institute, United States Peter Schiemann, Widler & Schiemann AG, Switzerland
Description
This session facilitates the development of a systematic, prioritized, risk-based approach to quality management of clinical trials that supports the principles of GCP and complements existing quality practices, requirements, and standards.
Learning Objectives:
Discuss approaches to clinical trial oversight
Identify the critical aspects of trials that should be the focus on to create quality systems
Describe an integrated model of quality management that will promote more efficient approaches to design, conduct, and oversight of clinical trials.
Learning Objectives:
Discuss approaches to clinical trial oversight
Identify the critical aspects of trials that should be the focus on to create quality systems
Describe an integrated model of quality management that will promote more efficient approaches to design, conduct, and oversight of clinical trials.
This session is a part of:
Handout Online
