http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Therapeutic risk management of medicines
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 ra.
Front Cover; Therapeutic risk management of medicines; Copyright; Contents; List of figures and tables; Figures; Tables; List of abbreviations; Acknowledgements; Foreword; About the authors; Additional contributors; Part 1 Background to therapeutic risk management; 1 Introduction; 1.1 The importance of therapeutic risk management; 1.2 Relevant audiences for and structure of this book; 2Basic principles of therapeutic risk management; 2.1 What is therapeutic risk management?; 2.2 The benefit-risk balance of a medicine; 2.3 Participants in therapeutic risk management.
2.4 Risk management during the product lifecycleNotes; References; 3The evolution of therapeutic risk management; 3.1 The importance of a historical perspective; 3.2 The early foundations for therapeutic risk management; 3.3 Major drug safety incidents that influenced risk management; 3.4 Risk minimisation emerges for effective but risky medicines; 3.5 The modern era of risk management; References; 4Risk management in the European Union; 4.1 Overview of the risk management approach in the EU; 4.2 The EU-RMP; 4.3 The periodic safety update report (PSUR); Notes; References.
5Risk management in the United States5.1 Overview of the US risk management approach; 5.2 Risk evaluation and mitigation strategies (REMS); 5.3 Experience of REMS in practice; 5.4 Other US risk management guidance and requirements; Notes; References; 6Overview of risk management around the world; 6.1 Risk management varies around the world; 6.2 Comparing EU and US approaches to risk management; 6.3 Risk management in other advanced markets; 6.4 Risk management in emerging markets; Note; References; Part 2 Developing a risk management plan.
7Developing a safety specification and selecting risks7.1 Structure of a safety specification; 7.2 Contents of an EU-RMP safety specification; 7.3 Selecting important risks and missing information; 7.4 Practical advice for writing a safety specification; References; 8Pharmacovigilance planning; 8.1 Overview of pharmacovigilance planning; 8.2 The EU-RMP pharmacovigilance plan; 8.3 Pharmacovigilance planning in the US; 8.4 Routine pharmacovigilance activities; 8.5 The need for and selection of additional pharmacovigilance activities; 8.6 Types of additional pharmacovigilance activities; Notes.
Stephen J. Mayall and Anjan K. Banerjee.
Drug-Related Side Effects and Adverse Reactions
Woodhead Publishing series in biomedicine ; no. 30