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SUB01: Orphan Drug Designation in the USA and Europe

SUB01: Orphan Drug Designation in the USA and Europe

  • 30 Day Money Back Guarantee
  • Completion Certificate
  • 24/7 Technical Support

Highlights

  • On-Demand course

  • 1 hour 30 minutes

  • Intermediate level

Description

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

Course Content

  1. SUB01: Orphan Drug Designation in the USA and Europe

About The Provider

Zenosis
Zenosis
Dundee
We specialise in Pharmaceutical & Biotech courses for healthcare professionals, as well as a suite of essential courses for regulatory and statutory business compliance. As a member of the CPD, you can be assured that our courses meet exacting standards and deliver a compelli...
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