DIA 48th Annual Meeting
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Vaccines: FDA and Japan Perspectives
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
163
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Florence Houn, FDA Alumni Association, United States
PRESENTER
(S):
Yoshikata Furuya, MSD K.K., Japan
Maureen Hess, FDA, United States Sara Gagneten, FDA, United States
Description
Perspectives from FDA CBER vaccines office on vaccine development and external communications policies, along with industry views on regulation and development from Japan will be presented.
Learning Objectives:
Discuss current CBER policies and interpretations of regulations for vaccine development
Describe what triggers transparency regarding vaccine communications with the public and what partnerships in communications CBER has for vaccines
Describe vaccine development for Japan and special challenges.
Learning Objectives:
Discuss current CBER policies and interpretations of regulations for vaccine development
Describe what triggers transparency regarding vaccine communications with the public and what partnerships in communications CBER has for vaccines
Describe vaccine development for Japan and special challenges.
This session is a part of:
Handout Online
