DIA 48th Annual Meeting
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Natural History Studies for Rare Diseases and Orphan Conditions
Track
:
Track 18: Rare/Neglected Diseases
Program Code:
346
Date:
Wednesday, June 27, 2012
Time:
10:00 AM to 11:30 AM
EST
CHAIR
:
Annette Stemhagen, United BioSource Corporation, United States
PRESENTER
(S):
Annette Stemhagen, United BioSource Corporation, United States Marshall Summar, Childrens National Medical Center, United States
Anne Pariser, FDA, United States
Description
This session presents an overview of the design, conduct, and benefits of natural history studies of rare diseases and orphan conditions from varied perspectives of researchers, patients and a regulatory agency.
Learning Objectives:
Discuss the need for natural history studies in drug development
Describe the types of natural history studies and their strengths and weaknesses
Define the key elements of an orphan disease natural history study Discuss FDA initiatives regarding rare diseases.
Learning Objectives:
Discuss the need for natural history studies in drug development
Describe the types of natural history studies and their strengths and weaknesses
Define the key elements of an orphan disease natural history study Discuss FDA initiatives regarding rare diseases.
This session is a part of:
Handout Online
