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The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.
This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.
The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.
The eCTD is mandatory for all applications for marketing approval and all subsequent related submissions in the European Economic Area, the USA and Canada. Other countries intend to make its use mandatory. The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the CTD to include information on variations, renewals and amendments, so that it is no longer a static document but is updatable throughout the life of the product. This module outlines the eCTD specification, discusses the approach to regional differences in dossiers, and provides guidance on creation of an eCTD submission. The module provides a training and reference tool that will be of particular value to those new to the use of the format.
Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included
Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + CPD Accreditation | Assessment & Tutor Support Included