DIA 48th Annual Meeting
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Pediatric Drug Development Progress: 15 Years Later and Across the Globe
Track
:
Track 17: Global Regulatory
Program Code:
121
Date:
Monday, June 25, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
William Rodriguez, FDA, United States
PRESENTER
(S):
Agnès Saint-Raymond, European Medicines Agency, European Union, United Kingdom
Mansoor Khan, FDA, United States
William Rodriguez, FDA, United States
Description
Cooperative efforts between EMA and FDA have resulted in addressing many study issues. The benefits of these exchanges and existing issues with extrapolation and formulations will be discussed.
Learning Objectives:
Discuss usefulness of collaborative interactions among regulators
Describe the outreach approaches to Latin America
Discuss issues involving extrapolation and formulations.
Learning Objectives:
Discuss usefulness of collaborative interactions among regulators
Describe the outreach approaches to Latin America
Discuss issues involving extrapolation and formulations.
This session is a part of:
Handout Online
