DIA 2013 49th Annual Meeting
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How Will Risk-adapted Clinical Trials Be Inspected?
Track
:
Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code:
314
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
Location:
156AB
CHAIR
:
John Poland, PhD (SCHNON), Senior Director, Regulatory Policy and Compliance, Covance Clinical Development Services, United Kingdom
SPEAKER
(S):
Ann Meeker-O'Connell, MS (SPKAGY), Senior Director, QA Clinical Strategy Team Lead, Janssen Pharmaceutica Inc., United States Fergus Sweeney, PhD (SPKAGY), Head of Sector, Compliance and Inspection, European Medicines Agency, European Union, United Kingdom Mike Sobczyk, MSc (SPKNON), Senior Director, Regulatory Compliance, Gilead Sciences, Inc., United States
Description
The particular challenges posed by GCP inspection of a risk-adapted clinical trial, and how they may be addressed, will be analyzed and discussed in terms of regulatory agency expectations and practical examples.
This session is a part of:
This session is a part of: