DIA 48th Annual Meeting
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Challenges of Orphan Drugs in the US, EU, and Japan
Track
:
Track 18: Rare/Neglected Diseases
Program Code:
149
Date:
Monday, June 25, 2012
Time:
1:30 PM to 3:00 PM
EST
CHAIR
:
Noriaki Murao, Merz Pharmacuticals GmbH, Japan
PRESENTER
(S):
Klaus Rose, Klausrose Consulting, Switzerland Kazuishi Sekino, Musashino University, Japan
Gayatri Rao, FDA, United States
Description
This session addresses the current status and forthcoming activities related to orphan drugs in the US, EU, and Japan. Orphan drug development is obviously essential in these regions, and the provisions in place on drugs including rare diseases are often passed over. We will also address the unique market situation of orphan drugs in the US and development and commercialization strategies of orphan drugs in each region.
Learning Objectives:
Describe an overview of the regulation and development on orphan drugs in US, EU and Japan
Discuss the development and commercialization strategies of orphan drugs in the US, EU, and Japan.
Learning Objectives:
Describe an overview of the regulation and development on orphan drugs in US, EU and Japan
Discuss the development and commercialization strategies of orphan drugs in the US, EU, and Japan.
This session is a part of:
Handout Online
