DIA 48th Annual Meeting
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Postapproval Change Pathways in EU and US: Challenges and Opportunities for Harmonization
Track
:
Track 12: Pharmaceutical Quality
Program Code:
142
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Christine Moore, FDA, United States
PRESENTER
(S):
Christine Moore, FDA, United States Emer Cooke, European Medicines Agency, United Kingdom Moheb Nasr, GlaxoSmithKline, United States
Description
This session will discuss the pathways, similarities, and differences for submitting postapproval changes to an approved Marketing Authorization to the EMA and a supplement to an approved NDA/ANDA to the USA. Speakers from FDA, EMA, and industry will provide a forward-looking view on current challenges of postapproval changes and on potential opportunities for expansion of risk and science based approaches.
Learning Objectives:
Identify the different pathways for postapproval changes to FDA and EMA
Describe postapproval similarities and differences.
Learning Objectives:
Identify the different pathways for postapproval changes to FDA and EMA
Describe postapproval similarities and differences.
This session is a part of:
Handout Online
