DIA 48th Annual Meeting
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Meet the Regulators: Helping You Ensure GCP Compliance by Knowing the Most Frequent and Serious Findings
Track
:
Track 19: SIAC Showcase
Program Code:
280
Date:
Tuesday, June 26, 2012
Time:
3:30 PM to 4:30 PM
EST
CHAIR
:
Munish Mehra, Quantum Biopharma, United States
PRESENTER
(S):
Leslie Ball, FDA, United States Fergus Sweeney, European Medicines Agency, United Kingdom
Description
This showcase will bring together regulatory authority compliance experts from FDA and EMA who will share their perspective on inspections and common areas of GCP noncompliance. Developed by the Good Clinical Practice and Quality Assurance (GCP) SIAC.
Learning Objectives:
Discuss frequently occurring GCP violations from FDA inspections
Identify what to focus on from a GCP compliance standpoint.
Learning Objectives:
Discuss frequently occurring GCP violations from FDA inspections
Identify what to focus on from a GCP compliance standpoint.
This session is a part of:
Handout Online
