QUESTIONSExL Pharmas Orphan Product Development and Post Marketing Commitments (Porph)
Venue: Webinar
Location: Webinar, Webinar, United States
| Event Date/Time: May 06, 2009 | |
| Registration Date: Apr 06, 2009 | |
| Early Registration Date: Apr 17, 2009 |
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The Orphan Products Regulations were issues in 1992, but Orphan Product Development has hardly been static:
* What has changed and what should sponsors be aware of as they are developing products for rare diseases?
* Especially where the numbers of patients studied has been small, what are the subsequent cost issues with requirements for more stringent follow-up of adverse events?
* If a drug product is used in a small population how can costs be contained and reimbursement be obtained?
* What companies wish to become involved in rare disease drug development?
* Why do large or small companies become involved?
* What impact is seen by the emergence of personalized medicine?
* What has changed and what should sponsors be aware of as they are developing products for rare diseases?
* Especially where the numbers of patients studied has been small, what are the subsequent cost issues with requirements for more stringent follow-up of adverse events?
* If a drug product is used in a small population how can costs be contained and reimbursement be obtained?
* What companies wish to become involved in rare disease drug development?
* Why do large or small companies become involved?
* What impact is seen by the emergence of personalized medicine?
Venue
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