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US Conference on Rare Diseases & Orphan Products 2013
The New Era in Health Care

October 7-9 | North Bethesda, MD
Bethesda North Marriott Hotel and Conference Center


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GO About Rare Diseases 2013

Pictures from the 2013 US Conference on Rare Diseases and Orphan Products: New Era in Healthcare

Conference held October 7-9, 2013 at the Bethesda North Marriott Hotel and Conference Center in North Bethesda, MD. This conference was sponsored by NORD and DIA (the Drug Information Association). 


US Conference on Rare Diseases and Orphan Products




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Co-Sponsored by:

DIA Fifty Years: 1964-2014

NORD 30th Anniversary Logo


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US Conference on Rare Diseases & Orphan Products: The New Era in Health Care

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GO Partners

Thank you to our Co-sponsor
 
NORD 30th Anniversary Logo
 

Thank you to our Collaborators
 
FDA                  Eurodis  
 National Center for Advancing Translational Sciences

GO Registration Fees

Government (Full Time)  $500.00 
Charitable Nonprofit/Academia  $800.00
Industry  $1665.00
Industry (As of 09/17/2013)  $1865.00

Patient Organizations & Patients are invited to attend the US Conference on Rare Diseases and Orphan Products at a reduced registration fee of $200. Online registration is not available for this rate. To register, please submit a copy of the registration form and submit the form by fax to +1.215.442.6199.
 
Questions: Contact Carrie Dunn at the DIA office by telephone 215.442.6181 or email Carrie.Dunn@diahome.org.

Group Discounts
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

Submit a registration form by fax to +1.215.442.6199.

Registration Questions? Contact CustomerService@DIAHome.org or +1.888.257.6457.

GO Related Events

DIA Recommends the Following Related Meetings & Training

SAVE THE DATE  - FDA Orphan Product Designation and Grant Workshop

Register Online

 

Workshop Update: FDA OOPD is continuing to plan for the FDA Orphan Product Designation and Grants Workshop as scheduled on October 4, 2013, however in the event of a Federal government shutdown, we may need to reschedule the workshop for a future date.  If the Federal government remains closed on October 3, 2013, OOPD will cancel the workshop and reschedule for a future date.

Registration is now open for the FDA/EMA Orphan Products Designation and Grant Workshop at the FDA White Oak Campus in Silver Spring, MD, on Friday, October 4, 2013, 8:30 am – 4:00 pm.  This one-day workshop is designed to provide valuable information about the EMA and FDA Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as to academics.  There will be no registration fee for the workshop,however registration is required.
 
All participants are welcome to register for the morning sessions which will provide an overview of the EMA and FDA Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation Program, the Orphan Products Grant programs.  The morning sessions will also be available by webcast.   
 
The afternoon session (no webcast),  provides an opportunity for appropriately registered participants to have one-on-one meetings with FDA staff members onsite, to discuss the specifics on how to apply for an orphan product grant, a HUD designation, or orphan drug designation.  It also provides for videoconference sessions with EMA staff representatives on EMA orphan drug designation. Participants requesting one-on-one meetings are expected to bring information for at least one candidate orphan drug or device that holds promise for the treatment of a rare disease or condition in order to discuss the processes for putting together an application.  In addition, participants in the HUD or orphan drug designation one-one-one sessions are highly encouraged to come prepared with a working draft submission of their particular promising therapy in order to maximize the utility of the one-on-one meetings.

Registration will be limited to 240 participants for the morning session, of which approximately 50 teams (up to 150 participants) may register for the one-on-one sessions.
 
Questions about the FDA Orphan Product Designation and Grant Workshop? Contact Eleanor Dixon-Terry at Eleanor.Dixon-Terry@fda.hhs.gov.
 
The FDA/EMA Orphan Product Designation and Grant Workshop is conducted in partnership with the European Organisation for Rare Disease (EURORDIS), Genetic Alliance, and the National Organization for Rare Disorders (NORD).

GO Patient Organizations & Patients

DIA and NORD invite Patient Organizations and Patients to attend the US Conference on Rare Diseases and Orphan Products to network with other stakeholders in the Rare Diseases Community.

Patient Organizations & Patients are invited to attend the US Conference on Rare Diseases and Orphan Products at a reduced registration fee of $200.  Online registration is not available for this rate.  To register, please submit a copy of the registration form and submit the form by fax to +1.215.442.6199.
 
Please note: A limited number of scholarships are available.  View Guidelines/Submit Application for the Patient Organization Scholarships.  The Application Deadline is Monday, August 12


GO Pre-Conference Tutorial

Sunday, October 6, 2013; 1:30-5:00 PM

Overview of The Regulatory frameworks and Opportunities for Orphan Medicinal Products (OMPs)

Tutorial Instructor:
Martine Zimmermann, PharmD
Vice President, Global Regulatory Affairs
Alexion Pharma International Sàrl

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