Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle
Get a quick, expert overview of risk management in transfusion medicine from Dr. James Mills Barbeau. This practical resource presents a summary of today’s state-of-the-art techniques for reducing harm during all phases of transfusion practice, including blood collection, testing, processing, clinical assessment, and transfusion. It’s an easy-to-read, one-stop resource for managing and mitigating the various levels of risk in a variety of transfusion settings and scenarios. Presents a well-rounded perspective on quality assurance, blood supply testing, clinical risk, ethical and legal considerations, and transfusion-transmitted infectious diseases. Demonstrates how transfusion risk-management programs add value to health care institutions by enhancing a culture of safety, improving the institution’s reputation, and improving the bottom line. Consolidates today’s available information on risk management in blood transfusion medicine into one convenient resource.
|Author||: Bruno Horisberger|
|Release Date||: 1989|
|ISBN 10||: 9780387505343|
|Pages||: 210 pages|
This volume, a tribute to the work of Robert Gilmer, consists of twenty-four articles authored by his most prominent students and followers. These articles combine surveys of past work by Gilmer and others, recent results which have never before seen print, open problems, and extensive bibliographies. The entire collection provides an in-depth overview of the topics of research in a significant and large area of commutative algebra.
|Release Date||: 1998|
|Pages||: 326 pages|