De Vere Venues , London, UK
Nov 10 2011 or Nov 11 2011
DIA/EMA/FDA are pleased to announce two 1-day workshops to provide regulatory assistance to sponsors developing orphan drug designation applications intended for regulatory submission. Participants can register for a workshop on either 10 November or 11 November 2011. It is an opportunity for biotechnology companies, small and medium-sized enterprises, larger pharmaceutical firms and academics to spend the day in creation of applications for orphan status designation. These workshops are designed to simplify and demystify entry into orphan drug development. Selected participants will be expected to bring draft applications for at least one candidate orphan drug that holds promise for the treatment of a rare disease. This will allow participants to directly engage in the practical matter of constructing an application for orphan status designation. To maximise the benefits of this workshop, we encourage you to come prepared with a working draft submission of a particular promising therapy. Registration is limited (maximum of 3 persons per organisation) and is accepted on a first come-first served basis. The final date for registration is 3 November 2011; onsite registration will not be available for these workshops. Prior to registration for this workshop, prospective participants must submit the following information to: Jim Bona at +1 301.796.8673 or James.Bona@fda.hhs.gov - Date of desired workshop
- Names of proposed participants (maximum of 3 persons per organisation)
- 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 within EMA/FDA. Identification of participants and their companies will not be disclosed by the EMA or by the FDA or DIA. Once you have received approval from FDA, please complete the registration form and send to DIA.
Event Code:
11120
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