A reliable and useful manual for creating, carrying out, and assessing risk management strategies for medications worldwide is therapeutic risk management of medicines. It describes how to evaluate risks and balance benefits over risks, plan and implement pharmacovigilance and risk reduction initiatives, and communicate with important stakeholders in an efficient manner. Many high-profile drug safety incidents and the need for improved access to potentially hazardous but effective treatments led to the development of a more methodical approach to managing the risks associated with pharmaceuticals. The last ten years have seen a rapid evolution of regulatory requirements. In the EU, new pharmaceuticals must have risk management plans (RMPs), and in the US, some medications require a risk evaluation and mitigation strategy (REMS). This book is an accessible resource that enhances the current regulatory guidance by delving deeper into important topics and their real-world applications. It is divided into chapters that cover the history of therapeutic risk management, RMP development techniques, RMP implementation, and the field's ongoing evolution. The topic is crucial for regulators and healthcare policymakers alike, as well as for the biotechnology and pharmaceutical industries. Selected industry experts have contributed to some of the chapters.
