Courses

PV06: Urgent Safety Restrictions An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorisation for a medicinal product in Europe. This module describes the principles and procedures for USRs. Who will benefit…

PV04: Risk Management Planning for Medicinal Products Proactive risk management is a major component of good pharmacovigilance practice. This module 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. Who will benefit from this…

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence 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…