Therapeutic Risk Management of Medicines

1st Edition - March 13, 2014
Authors: Stephen J. Mayall, Anjan Swapu Banerjee
Language: English
Paperback ISBN:
9 7 8 - 0 - 0 8 - 1 0 1 4 1 7 - 2
Hardback ISBN:
9 7 8 - 1 - 9 0 7 5 6 8 - 4 8 - 0
eBook ISBN:
9 7 8 - 1 - 9 0 8 8 1 8 - 2 7 - 0

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explai… Read more

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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.

List of figures and tables FiguresTablesList of abbreviationsAcknowledgementsForeword An appreciation by I Ralph EdwardsAbout the authorsAdditional contributorsPart 1: Background to therapeutic risk management 1. Introduction Abstract:1.1 The importance of therapeutic risk management1.2 Relevant audiences for and structure of this book2. Basic principles of therapeutic risk management Abstract:2.1 What is therapeutic risk management?2.2 The benefit–risk balance of a medicine2.3 Participants in therapeutic risk management2.4 Risk management during the product life-cycleReferences3. The evolution of therapeutic risk management Abstract:3.1 The importance of a historical perspective3.2 The early foundations for therapeutic risk management3.3 Major drug safety incidents that influenced risk management3.4 Risk minimisation emerges for effective but risky medicines3.5 The modern era of risk managementReferences4. Risk management in the European Union Abstract:4.1 Overview of the risk management approach in the EU4.2 The EU-RMP4.3 The periodic safety update report (PSUR)References5. Risk management in the United States Abstract:5.1 Overview of the US risk management approach5.2 Risk evaluation and mitigation strategies (REMS)5.3 Experience of REMS in practice5.4 Other US risk management guidance and requirementsReferences6. Overview of risk management around the world Abstract:6.1 Risk management varies around the world6.2 Comparing EU and US approaches to risk management6.3 Risk management in other advanced markets6.4 Risk management in emerging marketsReferencesPart 2: Developing a risk management plan 7. Developing a safety specification and selecting risks Abstract:7.1 Structure of a safety specification7.2 Contents of an EU-RMP safety specification7.3 Selecting important risks and missing information7.4 Practical advice for writing a safety specificationReferences8. Pharmacovigilance planning Abstract:8.1 Overview of pharmacovigilance planning8.2 The EU-RMP pharmacovigilance plan8.3 Pharmacovigilance planning in the US8.4 Routine pharmacovigilance activities8.5 The need for and selection of additional pharmacovigilance activities8.6 Types of additional pharmacovigilance activitiesReferences9. Assessing the need for risk minimisation Abstract:9.1 Why evaluating the need for risk minimisation is important9.2 Medication errors are a major source of risk9.3 Evaluation of need for risk minimisation within EU-RMPs and REMS9.4 A multi-step approach to evaluate the need for risk minimisation9.5 Alternative techniques for evaluating the need for risk minimisationReferences10. Developing risk minimisation plans/risk mitigation strategies Abstract:10.1 Overview of risk minimisation10.2 Risk minimisation plan content in EU-RMPs and REMS10.3 Optimising routine risk minimisation measures10.4 Risk minimisation tool options10.5 A multi-step approach to select appropriate risk minimisation tools10.6 Factors to consider when designing a risk minimisation programmeReferencesPart 3: Implementation of risk management plans 11. Evaluating the effectiveness of risk minimisation Abstract:11.1 Requirements for the assessment of risk minimisation11.2 Developing a risk minimisation evaluation11.3 Selecting appropriate methods for a high-quality evaluation11.4 Established and innovative evaluation techniques11.5 Consequences of risk minimisation effectiveness evaluation11.6 Effectiveness evaluation challengesReferences12. Implementing risk management activities Abstract:12.1 Overview of risk management implementation12.2 Configuring companies for effective risk management12.3 Developing a risk management plan document12.4 Implementing pharmacovigilance activities12.5 Implementing risk minimisation activities12.6 Risk management life-cycle activities12.7 Integrating risk management with other activitiesReferences13. Effective interactions with health authorities Abstract:13.1 Overview of regulatory authority interactions13.2 The EU regulatory system for risk management13.3 The US regulatory system for risk management13.4 Optimising interactions between companies and regulators13.5 Preparing for regulatory meetingsReferencesPart 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 DRMP14.3 Evolution of a DRMP during development14.4 Developmental pharmacovigilance and risk minimisation activitiesReferences15. Benefit–risk assessment and public communication Abstract:15.1 Overview of benefit–risk balance15.2 Challenges for assessment of benefit–risk balance15.3 Improving benefit–risk evaluation15.4 Public communication of benefit–risk balanceReferences16. The commercial importance of risk management and risk-sharing schemes Abstract:16.1 Managing therapeutic and funding risks16.2 Commercial importance of therapeutic risk management16.3 The commercial value of risk-sharing agreements16.4 Creating added value and synergy in post-launch programmesReferences17. Learnings from other types of risk management Abstract:17.1 Other types of risk management in the pharmaceutical industry17.2 Risk management in other industriesReferences18. The outlook for therapeutic risk management Abstract:18.1 The future of therapeutic risk managementReferencesIndex

Stephen J. Mayall

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

Principal Consultant at Pope Woodhead & Associates.

Anjan Swapu Banerjee

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

Deputy Managing Director (Deputy CEO) of Pope Woodhead & Associates and Head of Development Consulting.

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