126 Good Manufacturing Practice (GMP) courses

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.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.

In this course we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.