DIA 48th Annual Meeting
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Defining Quality in Clinical Trials
Track
:
Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code:
114
Date:
Monday, June 25, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
John Poland, Covance Clinical Development Services, United Kingdom
PRESENTER
(S):
Mike Sobczyk, Gilead Sciences, Inc., United States
Fergus Sweeney, European Medicines Agency, United Kingdom Leslie Ball, FDA, United States
Description
Latest progress in FDA and EMA initiatives on developing a new approach to quality in clinical trials, together with current expectations and practical examples from recent experience, will be analyzed and discussed.
Learning Objectives:
Discuss current FDA and EMA expectations for quality in clinical trials
Describe the progress in the development of a harmonized regulatory approach to the use of risk-based quality management systems in clinical trials.
Learning Objectives:
Discuss current FDA and EMA expectations for quality in clinical trials
Describe the progress in the development of a harmonized regulatory approach to the use of risk-based quality management systems in clinical trials.
This session is a part of:
Handout Online
