686 Manufacturing courses delivered Online

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 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.

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 regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

Manufacturers of medicines and healthcare products must establish, validate and maintain an equipment cleaning programme. This is a regulatory requirement because validated cleaning procedures contribute to the assurance of product purity and safety. This module provides a comprehensive account of equipment cleaning validation requirements and procedures. It follows the work of a pharmaceutical company's validation team as they establish and validate the cleaning program for a new production line.

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

This foundation-level module is the ideal introduction for new entrants to the field of pharmaceutical regulatory affairs and compliance. It describes the principal requirements that must be satisfied to gain and maintain approval to market medicinal products in the USA and Europe. The legal framework and the roles of major players in regulation are presented. The life-cycle of a drug is outlined. The various procedures available for assessment and approval of products are described and their requirements outlined. Obligations to be fulfilled after marketing approval are discussed.