DIA 48th Annual Meeting
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Orphan Drug Development: Global Regulatory Challenges and Initiatives
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
359
Date:
Wednesday, June 27, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Kinnari Patel, Bristol-Myers Squibb Company, United States
PRESENTER
(S):
Timothy Cote, National Organization For Rare Disorders (NORD), United States Marlene Haffner, Haffner Associates, LLC, United States Jonca Bull, Novartis Pharmaceuticals Corporation, United States
Description
This session will focus on critical need for developing orphan drugs, review of global orphan drug development challenges, and provide information on various strategies designed to overcome these challenges.
Learning Objectives:
Discuss updates in regulatory policy and industry activities in orphan drug development
Discuss key clinical development challenges in demonstrating substantial evidence of effectiveness for orphan diseases
Identify initiatives to address clinical development and regulatory approval challenges.
Learning Objectives:
Discuss updates in regulatory policy and industry activities in orphan drug development
Discuss key clinical development challenges in demonstrating substantial evidence of effectiveness for orphan diseases
Identify initiatives to address clinical development and regulatory approval challenges.
This session is a part of:
Handout Online
