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
John has worked in Regulatory Affairs since 1979. He joined Covance in 1988 to establish the European regulatory submissions function, was subsequently responsible for managing GCP inspections of Covance by European regulatory agencies, and now advises on global regulatory policy issues.
PRESENTER
(S):
Mike Sobczyk, Gilead Sciences, Inc., United States
PhD in pharmacology 1986 Joined EMEA in 1999. Coordination of GCP and Pharmacovigilance inspection. Chairman of the GCP Inspectors Working Group and Ad Hoc Pharmacovigilance Inspectors Working Group. Business analyst for the EudraCT database.
Dr. Ball is Director, Division of Scientific Investigations, CDER, FDA. She joined the FDA in 1996. Dr. Ball graduated from Georgetown University School of Medicine, where she completed a residency in Pediatrics. She completed a fellowship in Pediatric Infectious Diseases at Walter Reed.
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.