DIA 48th Annual Meeting
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FDA and European Medicines Agency Collaboration: GCP Inspections and Beyond
Track
:
Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code:
317
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Leslie Ball, FDA, United States
PRESENTER
(S):
Fergus Sweeney, European Medicines Agency, United Kingdom Karena Cooper, FDA, United States
Description
This session will discuss the progress of the FDA and EMA GCP initiative, present areas of current focus, and preview future collaborations on inspections as well as GCP policy and guidance.
Learning Objectives:
Discuss how the FDA and EMA collaborate on inspections involving clinical research
Identify key differerences and similarities between the FDA and EMA policies and guidance in GCP
Outline areas of future collaboration between the FDA and EMA.
Learning Objectives:
Discuss how the FDA and EMA collaborate on inspections involving clinical research
Identify key differerences and similarities between the FDA and EMA policies and guidance in GCP
Outline areas of future collaboration between the FDA and EMA.
This session is a part of:
Handout Online
