Orphan Drug Designation in the USA and Europe

Online Course • grapl

About the CPD course

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.

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grapl

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grapl

grapl is a UK based digital learning and development specialist, authoring and designing Zenosis® courses to provide an extensive eLearning library for the pharmaceutical, biotech and medicinal products sector. This learning can be delivered via the customers LMS, the grapl LMS or its social, knowledge and collaborative CloudRooms platform. Continuously updated to reflect regulatory changes, Zenosis® courses are trusted to educate their people by some of the worlds leading companies.