DIA 48th Annual Meeting
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Pediatric Development in the US: Implementation of 2007 PREA and BPCA Against a Backdrop of the EU Pediatric Legislation
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
225
Date:
Tuesday, June 26, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Chin Koerner, Novartis Pharmaceuticals Corporation, United States
PRESENTER
(S):
Klaus Rose, Klausrose Consulting, Switzerland Ronald Portman, Bristol-Myers Squibb Company, United States Lisa Mathis, FDA, United States
Description
With the passage of the US and EU pediatric legislation, companies are challenged to meet the requirements of FDA and EMA. Differing timelines, processes and standards require well managed interactions with health authorities to achieve consensus.
Learning Objectives:
Summarize convergences and divergences between US and EU health authority policies and practices when developing a global pediatric strategy
Discuss current recommendations for interacting with FDA on pediatric development.
Learning Objectives:
Summarize convergences and divergences between US and EU health authority policies and practices when developing a global pediatric strategy
Discuss current recommendations for interacting with FDA on pediatric development.
This session is a part of:
Handout Online
