Therapeutic Risk Management of Medicines


  • Stephen J. Mayall, Pope Woodhead & Associates, UK
  • Anjan Swapu Banerjee, Pope Woodhead & Associates, UK

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.

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Pharmacists and biotechnologists; Healthcare policymakers and regulators


Book information

  • Published: March 2014
  • Imprint: Woodhead Publishing
  • ISBN: 978-1-907568-48-0


"...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

Table of Contents


Chapter 1 Introduction

1.1 The importance of therapeutic risk management

1.2 Relevant audiences for and structure of this book

Chapter 2 Basic 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 life-cycle

Chapter 3 The 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

Chapter 4 Risk 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)

Chapter 5 Risk management in the United States

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

Chapter 6 Overview 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


Chapter 7 Developing a safety specification and selecting risks

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

Chapter 8 Pharmacovigilance 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

Chapter 9 Assessing the need for risk minimisation

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

Chapter 10 Developing risk minimisation plans/risk mitigation strategies

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


Chapter 11 Evaluating the effectiveness of risk minimisation

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

Chapter 12 Implementing risk management activities

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

Chapter 13 Effective interactions with health authorities

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


Chapter 14 Development risk management plans

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

Chapter 15 Benefit-risk assessment and public communication

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

Chapter 16 The commercial importance of risk management and risk-sharing schemes

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

Chapter 17 Learnings from other types of risk management

17.1 Other types of risk management in the pharmaceutical industry

17.2 Risk management in other industries

Chapter 18 The outlook for therapeutic risk management

18.1 The future of therapeutic risk management