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Recorded Webinar
The clinical, regulatory and business challenges and rewards of Orphan Med development and approval EU and international
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
Hoss has been working in the rare disease drug development field for over 20 years in a regulatory and scientific capacity. He will provide insights which can help streamlining Orphan Drugs (O/Ds) development and improve the chances of success.
He will cover selecting an O/D disease target, clinical logistics, safety, optimising and ratifying the program based on consulting stakeholders the patients, physicians, regulatory and health assessment bodies. Some O/Ds are available in emerging markets but the barriers to approval in EU or US appear formidable; is there a way forward when the unmet need is high?
He will also touch on reimbursement as well as good business practice.
Therefore, in one presentation there is an opportunity for you to experience the current challenges and successes in the field of O/D development.
Areas Covered in the Webinar:
- What is the history of Orphans? How many are approved?
- How does FDA compare with EMA.
- Some Orphans are new drugs (NCE/NME) or new biologics are they not? Others are approved for non-rare conditions. Implications?
- What do stakeholders patients, doctors, health care provider bodies or regulators expect from an Orphan?
- What are the incentives for developing Orphans?
- Can we rely on Orphans approved in non-regulated regions used in US or EU under compassionate use?
- How safe are Orphan Medicines? How much is known of safety before an Approval?
- Safety of Orphans will be considered, the extent of the database, and relative risk compared to benefit and effectiveness.
Who should attend
Anyone who is interested in learning more on Orphan Drugs
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