"Do A Designation"
FDA Orphan Drug Workshop

Workshop Related Links

Workshop Brochure (coming soon)

FDA - Developing Products for Rare Diseses & Conditions

MN Specific Workshop Links

Radisson University Hotel-Minneapolis

Minneapolis-St. Paul International Airport (MSP)

Sponsorship

 

 

In partnership with

 

 

 

Center for Orphan Drug Research
College of Pharmacy
University of Minnesota

Tuesday, August 2 - Thursday, August 4, 2011

Target Audience

The FDA orphan drug workshop provides an opportunity for academics, biotechnology companies and larger pharmaceutical firms to spend two days creating an application for orphan status designation.

Description

This is a workshop, not a listenshop as participates will engage in the practical matter of constructing an application for orphan designation. 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. Over the two days, FDA staff from the Office of Orphan Products Development (OOPD) will provide regulatory assistance to sponsors to find regulatory paths forward. There will be an introductory lecture, but most of the time will be spent in application writing and individual one-on-one guidance sessions to develop the strongest possible orphan designation application. This application is to be submitted at the close of the workshop or within 30 days. *Participation in this workshop confers neither expedited processing nor preferential consideration of their applications.

For additional information see Workshop Brochure on the right.

Agenda

Tuesday, August 2 6:00-8:00pm
Registration check-in	5:00-6:00
Orientation to Application Process	6:00-7:00
Welcome Reception	7:00-8:30
Wednesday, August 3 7:30am - 5:00pm
Breakfast	7:30-8:00
Welcome	8:00-8:15
Workshop Orientation	8:15-8:30
Application Writing & One-on-One Guidance and Counseling with FDA	8:30-5:00
Sponsors will have one 45 minute and one 30 minute consultative session with an FDA OOPD staff member between 8:30am-5:00pm. Exact times will be scheduled at a later date. Lunch will be provided.
Thursday, August 4 7:30am - 5:00pm
Breakfast	7:30-8:00
Application Writing & One-on-One Staff Consultations	8:00-4:00
Wrap-up	4:00-5:00
Sponsors will have two (2) 20-minute follow-up sessions with an FDA OOPD staff member between 8:00am-4:00pm

Registration

Prior to registration for this workshop, prospective participants must submit the following information to James D. Bona, R.Ph., M.P.H at 301-796-8673 or james.bona@fda.hhs.gov:

• Names of proposed participants (no more than 3 for each product)
• Contact information
• Proposed orphan product for which an application will be developed
• Proposed rare diseases for said product

NOTE: Information regarding your proposed orphan product and rare disease for said product will be kept confidential. Identification of participants and their companies will not be disclosed by the FDA or the University of Minnesota.

Registration is limited to 50 companies or organizations (maximum of 3 persons per organization)and are accepted on a first come-first serve basis.

Registration Fees*
Registration fee is $1500 per participant for the workshop. Registration includes program materials, welcome reception on Monday evening; breakfast, lunch and snacks on Tuesday and Wednesday. Dinner is on your own.

* Registration fees are charged by the University of Minnesota to cover the costs of the workshop. FDA does not receive any of these funds and does not endorse any fundraising activities related to this workshop.

The final date for online registration and payment is July 15, 2011.

Refunds/Cancellation Policy
Cancellations, made in writing, before July 22th are charged a $250 administrative fee/per credit card. Cancellations after July 22th are non-refundable.

Welcome Reception

Please join your colleagues on Tuesday, August 2 from 6:00-8:00pm for a welcome reception to be held at the exclusive Campus Club, located on the 4th floor of Coffman Memorial Union.

Location and Transportation

The workshop will be held at the University of Minnesota-Twin Cities Campus, in Minneapolis on the East Bank.

Minneapolis - St. Paul International Airport (MSP) is located in St. Paul, MN and is a short cab ride to and from the workshop hotel (listed below).

Taxis from the MSP airport to the workshop hotel are approximately $34-$44.

There are several cab companies in theMinneapolis/St. Paul area. Listed below are some of those if you would like to call ahead to arrange transportation.

Rainbow Taxi: 612.332.1615
Yellow Taxi Company: 612.824.4444
Red & White Taxi: 612.871-1600
Global Taxi Service: 612.869.7373
Airport/Town Taxi: 612.331.8294

For public transportation in town such as the bus or light rail, please visit the Metro Transit web site to find schedules and fares.

Hotel Reservations

A block of rooms is being reserved at the Radisson University Hotel-Minneapolis. Details coming soon!

Items to Bring

We ask that you bring along a laptop with wireless Internet capabilities and a memory stick (Flash Drive).

Printing facilities will be available for participant use during the workshop. Wireless Internet connection will also be provided.

There is no formal dress attire for this workshop, business casual is appropriate. It can be difficult to control the room temperature on campus, so please be certain to dress in layers.

Contact Information

For questions regarding this event, please contact Continuing Pharmacy Education at the University of Minnesota via email at onlinece@umn.edu or toll free at 1-800-633-6638.