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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,...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Cambridge :
Woodhead Publishing,
�2014.
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| Colección: | Woodhead Publishing series in biomedicine ;
no. 30. |
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.