Description
This training program provides a comprehensive overview of the requirements and concepts necessary to attain a strong understanding of drug safety and pharmacovigilance.
Drug safety monitoring and risk management are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety and good pharmacovigilance practice (GVP), so that all staff are aware of the basic requirements. This program will provide students with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.
Product license holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimization action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources. The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through ‘data mining’ of large databases, observational studies of ‘real world’ prescription and use, to interventional clinical trials.
This program moves further to provide a guide to signal detection and management for approved products. The subject is presented as a process comprising four (4) stages: signal detection, signal validation, signal analysis and prioritization, and risk assessment and minimization.
This online program aims to supply the student with a guide that will help them understand signal detection and the proper management of approved products. The process for this subject matter is presented in four stages: minimization and risk assessment; prioritization and signal analysis; signal validation; and signal detection. Interventional clinical trials, observational studies of prescription, and their use in the real world, data mining through large databases, and traditional medical assessment of individual spontaneous reports of adverse events, are some of the methods used. The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.
Proactive risk management is a major component of good pharmacovigilance practice (GVP). This course sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products. This program is based on a variety of sources, such as CIOMS IX, ICH E2E, EU GVPs, FDA guidance for the industry, and GVP Module V (Rev 2, 2017).
In response to a safety signal, a regulatory action, called the Urgent Safety Restriction (USR), is taken. This action is intended to push an interim change to the marketing authorization’s terms for a medicinal product in Europe. Described within this program are the procedures and principles for Urgent Safety Restrictions (USRs).
Objectives contained within this area of the program are as follows: To train on what to do following a Urgent Safety Restriction, a specification for the requirements for a variation application is necessary; review an outline of the 24-hour procedure for a USR’s execution; offer a description of general regulatory requirements for initiation and preparation of a USR; provide a description of the triggering of a USR; and to offer an explanation of the purpose of Europe’s Urgent Safety Restrictions.
This program moves on and 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. Furthermore, this program will set 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.
Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This program details the process of planning and conducting such research, and analyzing and reporting the findings, to follow good pharmacoepidemiology practice.
Individual courses contained within this program are as follows: 1) Introduction to Drug Safety and Pharmacovigilance; 2) Urgent Safety Restrictions; 3) Risk Management Planning for Medicinal Products; 4) Signal Detection and Management in the Pharmacovigilance; 5) Good Pharmacoepidemiology Practice; 6) Safety Reporting in Clinical Trials (Adverse Event Reporting); and 7) Clinical Trial Safety Reporting Requirements in the EU and USA.
