The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Online Course • grapl

About the CPD course

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation; filing and maintenance of INDs. The IND and its role are defined; and the contexts in which it is required are specified. The information that must be included and the format in which it needs to be presented are outlined. The process of review by the FDA is described; and the outcomes and sponsor’s responses are discussed.

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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.