DIA 2013 49th Annual Meeting
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FDA/EMA/WHO Collaboration and Cooperation on Good Clinical Practice (GCP), Bioequivalence (BE) and Pharmacovigilance (PV) Inspections
Track
:
Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code:
353
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
156AB
CHAIR
:
Cynthia Kleppinger, MD (SCHAGY), Senior Medical Officer, Office of Scientific Investigations, CDER, FDA, United States
SPEAKER
(S):
Cynthia Kleppinger, MD (SPKAGY), Senior Medical Officer, Office of Scientific Investigations, CDER, FDA, United States Fergus Sweeney, PhD (SPKAGY), Head of Sector, Compliance and Inspection, European Medicines Agency, European Union, United Kingdom Lembit Rago, (SPKSUP), Coordinator for Quality Assurance and Safety for Medicines, World Health Organization (WHO), Switzerland
Description
This session will provide updates about the FDA's international collaborative inspection initiatives with the EMA and cooperative exchanges with the WHO. Included will be discussions of the FDA-EMA GCP initiative, the new BE initiative and information exchange regarding pharmacovigilance.
This session is a part of:
This session is a part of: