rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Therapeutic risk management of medicines
  name:
    name part: Mayall, Stephen J.
    role:
      role term: creator
  name:
    name part: Banerjee, Anjan K.
  name:
    name part: ScienceDirect (Online service)
  type of resource: text
  genre: Electronic books.
  origin info:
    place:
      place term: enk
    place:
      place term: Cambridge
    publisher: Woodhead Publishing
    date issued: ©2014
    date issued: 2014
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: remote
    extent: 1 online resource
  abstract: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  table of contents: 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.
  note: Stephen J. Mayall and Anjan K. Banerjee.
  subject:
    topic: Drugs
    topic: Side effects
  subject:
    topic: Drug-Related Side Effects and Adverse Reactions
  subject:
    topic: Médicaments
    topic: Effets secondaires
  subject:
    topic: MEDICAL
    topic: Pharmacology
  subject:
    topic: Drugs
    topic: Side effects
  classification: RM302.5
  classification: 615.7/042
  related item:
    title info:
      title: Woodhead Publishing series in biomedicine ; no. 30
  identifier: 1306674441
  identifier: 9781306674447
  identifier: 9781908818270
  identifier: 1908818271
  identifier: 9781907568480
  identifier: 598695 MIL
  identifier: http://proxy.library.tamu.edu/login
  record info:
    record content source: IDEBK
    record creation date: 140425
    record change date: 20260326200525.7
    record identifier: in00005754140
    language of cataloging:
      language term: eng