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Recorded Webinar
FDA approvals of Orphan Drugs and Rare Diseases: Integrating the patient voice into regulatory submissions
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA approvals of orphan drugs for rare diseases is at an all-time high with over 41 novel and innovative medicines approved in 2014. More frequently the FDA is requiring patient perspectives be included in regulatory filings and post-market surveillance programs. By definition, rare disease communities have small patient populations which makes it difficult for pharmaceutical and biotechnology companies to engage patients in longitudinal post market surveillance studies.
The traditional methods of leveraging CRO's in post market surveillance studies makes these programs costly and cumbersome for patients and investigators. There is a growing trend toward allowing patients to participate in post-market activities through patient registry and clinical data coordination programs. Case studies will be presented to illustrate how new models of tracking patients through patient self-report portals and by leveraging local physicians and testing labs to provide much of the data to support the program requirements.
This webinar will provide participants a high level understanding of:
- The need to collect patient reported quality of life and comparative effectiveness data
- Creative models to engage patients and caregivers in post market surveillance activities
- Case studies will be presented to illustrate successful methods of integrating patients
- Security and patient privacy considerations
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