Therapeutic Risk Management of Medicines - 1st Edition - ISBN: 9781907568480, 9781908818270

Therapeutic Risk Management of Medicines

1st Edition

Authors: Stephen J. Mayall Anjan Swapu Banerjee
Hardcover ISBN: 9781907568480
eBook ISBN: 9781908818270
Imprint: Woodhead Publishing
Published Date: 13th March 2014
Page Count: 448
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Table of Contents

  • List of figures and tables
    • Figures
    • Tables
  • List of abbreviations
  • Acknowledgements
  • Foreword
    • An appreciation by I Ralph Edwards
  • About the authors
  • Additional contributors
  • Part 1: Background to therapeutic risk management
    • 1. Introduction
      • Abstract:
      • 1.1 The importance of therapeutic risk management
      • 1.2 Relevant audiences for and structure of this book
    • 2. Basic principles of therapeutic risk management
      • Abstract:
      • 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 life-cycle
      • References
    • 3. The evolution of therapeutic risk management
      • Abstract:
      • 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
    • 4. Risk management in the European Union
      • Abstract:
      • 4.1 Overview of the risk management approach in the EU
      • 4.2 The EU-RMP
      • 4.3 The periodic safety update report (PSUR)
      • References
    • 5. Risk management in the United States
      • Abstract:
      • 5.1 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
      • References
    • 6. Overview of risk management around the world
      • Abstract:
      • 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
      • References
  • Part 2: Developing a risk management plan
    • 7. Developing a safety specification and selecting risks
      • Abstract:
      • 7.1 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
    • 8. Pharmacovigilance planning
      • Abstract:
      • 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
      • References
    • 9. Assessing the need for risk minimisation
      • Abstract:
      • 9.1 Why evaluating the need for risk minimisation is important
      • 9.2 Medication errors are a major source of risk
      • 9.3 Evaluation of need for risk minimisation within EU-RMPs and REMS
      • 9.4 A multi-step approach to evaluate the need for risk minimisation
      • 9.5 Alternative techniques for evaluating the need for risk minimisation
      • References
    • 10. Developing risk minimisation plans/risk mitigation strategies
      • Abstract:
      • 10.1 Overview of risk minimisation
      • 10.2 Risk minimisation plan content in EU-RMPs and REMS
      • 10.3 Optimising routine risk minimisation measures
      • 10.4 Risk minimisation tool options
      • 10.5 A multi-step approach to select appropriate risk minimisation tools
      • 10.6 Factors to consider when designing a risk minimisation programme
      • References
  • Part 3: Implementation of risk management plans
    • 11. Evaluating the effectiveness of risk minimisation
      • Abstract:
      • 11.1 Requirements for the assessment of risk minimisation
      • 11.2 Developing a risk minimisation evaluation
      • 11.3 Selecting appropriate methods for a high-quality evaluation
      • 11.4 Established and innovative evaluation techniques
      • 11.5 Consequences of risk minimisation effectiveness evaluation
      • 11.6 Effectiveness evaluation challenges
      • References
    • 12. Implementing risk management activities
      • Abstract:
      • 12.1 Overview of risk management implementation
      • 12.2 Configuring companies for effective risk management
      • 12.3 Developing a risk management plan document
      • 12.4 Implementing pharmacovigilance activities
      • 12.5 Implementing risk minimisation activities
      • 12.6 Risk management life-cycle activities
      • 12.7 Integrating risk management with other activities
      • References
    • 13. Effective interactions with health authorities
      • Abstract:
      • 13.1 Overview of regulatory authority interactions
      • 13.2 The EU regulatory system for risk management
      • 13.3 The US regulatory system for risk management
      • 13.4 Optimising interactions between companies and regulators
      • 13.5 Preparing for regulatory meetings
      • References
  • Part 4: Continuing evolution of risk management
    • 14. Development risk management plans
      • Abstract:
      • 14.1 Role of a development risk management plan (DRMP)
      • 14.2 Structure and content of a DRMP
      • 14.3 Evolution of a DRMP during development
      • 14.4 Developmental pharmacovigilance and risk minimisation activities
      • References
    • 15. Benefit–risk assessment and public communication
      • Abstract:
      • 15.1 Overview of benefit–risk balance
      • 15.2 Challenges for assessment of benefit–risk balance
      • 15.3 Improving benefit–risk evaluation
      • 15.4 Public communication of benefit–risk balance
      • References
    • 16. The commercial importance of risk management and risk-sharing schemes
      • Abstract:
      • 16.1 Managing therapeutic and funding risks
      • 16.2 Commercial importance of therapeutic risk management
      • 16.3 The commercial value of risk-sharing agreements
      • 16.4 Creating added value and synergy in post-launch programmes
      • References
    • 17. Learnings from other types of risk management
      • Abstract:
      • 17.1 Other types of risk management in the pharmaceutical industry
      • 17.2 Risk management in other industries
      • References
    • 18. The outlook for therapeutic risk management
      • Abstract:
      • 18.1 The future of therapeutic risk management
      • References
  • Index


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.

Key Features

  • 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


Pharmacists and biotechnologists; Healthcare policymakers and regulators


No. of pages:
© Woodhead Publishing 2014
Woodhead Publishing
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"...a must-have book for those working in the field of therapeutic risk management of medicines...very useful as a training book for new pharmacovigilance officers, but it is also useful for experienced staff…" --Drug Safety, 03-Oct-14

About the Authors

Stephen J. Mayall Author

Dr Stephen Mayall is a Principal Consultant at Pope Woodhead & Associates. He has over 15 years of consulting and project management experience in the global pharmaceutical industry, and has focused on therapeutic risk management since 2003. Steve has worked on the development and/or implementation of over 40 risk management plans, including EU-RMPs, REMS and development-stage RMPs. These have encompassed a diverse range of therapeutic areas, product types, life-cycle stages and client companies. He has also conducted a variety of other consulting projects for global pharmaceutical and biotechnology companies, covering communications, drug safety, clinical development, strategic marketing and in-licensing topics. This broader experience has provided valuable insights for placing risk management in a wider context within different organisations and healthcare systems. Steve has a Bachelor’s degree in natural sciences (biochemistry) from the University of Cambridge, and a PhD in cell biology from University College London.

Affiliations and Expertise

Pope Woodhead & Associates, UK

Anjan Swapu Banerjee Author

Dr Anjan “Swapu” Banerjee is Deputy Managing Director (Deputy CEO) of Pope Woodhead & Associates and Head of Development Consulting. He has wide experience of numerous global risk management programmes, is a member of the ENCePP network and has been involved in multiple EU and US regulatory filings, regulatory projects and the design of clinical development programmes. He is also a Faculty member in Regulatory, Drug Safety and Risk Management at the Institute of Biotechnology, Cambridge University. Anjan has over 15 years of experience in global pharmaceuticals, biotech, advanced therapies and devices in clinical development, regulatory, medical affairs and drug safety roles in addition to experience as a Management Consultant at McKinsey & Company. He has spent more than 30 years in healthcare, remaining clinically active as a part-time Honorary Consultant Surgeon at Bedford Hospital NHS Trust. He has completed UK higher medical training in pharmaceutical medicine (as well as general surgery) and has an MSc in pharmacoepidemiology. Anjan is MBBS, DM, MBA, FRCP(Edin), FRCS(Gen), FRCS(Glas), FAcadMEd, FICS, MFPM, FSB.

Affiliations and Expertise

Pope Woodhead & Associates, UK