DIA/FDA Orphan Drug Designation Workshop

Venue: The National Conference Center

Location: Lansdowne, Virginia, United States

Event Date/Time: Nov 02, 2011 End Date/Time: Nov 03, 2011
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In Collaboration with the National Organization
for Rare Disorders (NORD) and Genetic Alliance

November 2, 2011 or November 3, 2011
Two 1-Day Workshops
Registration is limited (maximum of 3 persons per organization) and is accepted on a first come—first served basis.
Please select your specified date of preference for attendance.
Registration closes October 24, 2011; on-site
registration will not be available for this workshop.

FDA is pleased to announce the continuation of the Orphan Drug Designation Workshop series, presenting an opportunity for academics, biotechnology companies and larger pharmaceutical firms to spend a full day in creation of applications for orphan status designation. This workshop is designed to simplify and demystify entry into orphan drug development by small biotechnology companies, academics and larger industry entities.
Selected participants will be expected to bring specific products for at least one candidate orphan drug that holds promise for the
treatment of a rare disease. This will allow you to directly engage in the practical matter of constructing an application for orphan
status designation. To maximize the benefi ts of this workshop, we encourage you to come prepared with a working draft submission of a particular promising therapy.

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