Click here to go to the previous page
Pediatric Drug Development Progress: 15 Years Later and Across the Globe
Program Code:
121
Date:
Monday, June 25, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Prof of Ped at George Washington U. since 1985, former Chair of Infect Dis. Children’s National Medical Center 1983-2000. He joined the FDA 7/2000. In 2007 he was appointed Science Director in OPT/OC/FDA. He has published results from the drug development pediatric initiatives in the literature.
|
PRESENTER
(S):
Agnès Saint-Raymond, European Medicines Agency, European Union, United Kingdom
Mansoor Khan, FDA, United States
Prof of Ped at George Washington U. since 1985, former Chair of Infect Dis. Children’s National Medical Center 1983-2000. He joined the FDA 7/2000. In 2007 he was appointed Science Director in OPT/OC/FDA. He has published results from the drug development pediatric initiatives in the literature.
|
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.