DIA 2013 49th Annual Meeting
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Postapproval Change Management: Challenges and Opportunities
Track
:
Track 12: Pharmaceutical Quality
Program Code:
410
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
Location:
153C
CHAIR
:
Christine M. V. Moore, PhD (SPKAGY), Acting Director, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
SPEAKER
(S):
Evdokia Korakianiti, PhD,MSc (SCHAGY), Head of Chemicals Section, Quality of Medicines, European Medicines Agency, European Union, United Kingdom Christine M. V. Moore, PhD (SPKAGY), Acting Director, Office of New Drug Quality Assessment, OPS, CDER, FDA, United States
Description
A robust postapproval global change management program is an essential part for any pharmaceutical quality system. This session will discuss the importance of a robust and current global change management system and the challenges and opportunities faced by both the pharmaceutical sector as well as the regulatory agencies.
This session is a part of:
This session is a part of: