Mayall / Banerjee Therapeutic Risk Management of Medicines

1. Auflage 2014
ISBN: 978-1-908818-27-0
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, Band 30, 448 Seiten

Reihe: Woodhead Publishing Series in Biomedicine

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. - 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

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.

Autoren/Hrsg.

Mayall, Stephen J.

Banerjee, Anjan Swapu

Inhaltsverzeichnis

1;Front Cover
;1
2;Therapeutic risk management of medicines;4
3;Copyright
;5
4;Contents;6
5;List of figures and tables
;10
5.1;Figures;10
5.2;Tables;13
6;List of abbreviations;16
7;Acknowledgements;24
8;Foreword;26
9;About the authors;30
10;Additional contributors;32
11;Part 1 Background to therapeutic risk management;34
11.1;1 Introduction
;36
11.1.1;1.1 The importance of therapeutic risk management;36
11.1.2;1.2 Relevant audiences for and structure of this book;38
11.2;2
Basic principles of therapeutic risk management;42
11.2.1;2.1 What is therapeutic risk management?;42
11.2.2;2.2 The benefit–risk balance of a medicine
;45
11.2.3;2.3 Participants in therapeutic risk management;48
11.2.4;2.4 Risk management during the product lifecycle;53
11.2.5;Notes;55
11.2.6;References;56
11.3;3
The evolution of therapeutic risk management;58
11.3.1;3.1 The importance of a historical perspective;58
11.3.2;3.2 The early foundations for therapeutic risk management;59
11.3.3;3.3 Major drug safety incidents that influenced risk management
;63
11.3.4;3.4 Risk minimisation emerges for effective but risky medicines;75
11.3.5;3.5 The modern era of risk management;81
11.3.6;References;86
11.4;4
Risk management in the European Union;94
11.4.1;4.1 Overview of the risk management approach in the EU;94
11.4.2;4.2 The EU-RMP;99
11.4.3;4.3 The periodic safety update report (PSUR);108
11.4.4;Notes;109
11.4.5;References;110
11.5;5
Risk management in the United States;112
11.5.1;5.1 Overview of the US risk management approach;112
11.5.2;5.2 Risk evaluation and mitigation strategies (REMS);113
11.5.3;5.3 Experience of REMS in practice;122
11.5.4;5.4 Other US risk management guidance and requirements;127
11.5.5;Notes;131
11.5.6;References;131
11.6;6
Overview of risk management around the world;134
11.6.1;6.1 Risk management varies around the world;134
11.6.2;6.2 Comparing EU and US approaches to risk management;138
11.6.3;6.3 Risk management in other advanced markets;140
11.6.4;6.4 Risk management in emerging markets;144
11.6.5;Note;148
11.6.6;References;148
12;Part 2 Developing a risk management plan

;152
12.1;7
Developing a safety specification and selecting risks ;154
12.1.1;7.1 Structure of a safety specification
;154
12.1.2;7.2 Contents of an EU-RMP safety specification
;156
12.1.3;7.3 Selecting important risks and missing information;161
12.1.4;7.4 Practical advice for writing a safety specification
;166
12.1.5;References;167
12.2;8
Pharmacovigilance planning;170
12.2.1;8.1 Overview of pharmacovigilance planning;170
12.2.2;8.2 The EU-RMP pharmacovigilance plan;172
12.2.3;8.3 Pharmacovigilance planning in the US;174
12.2.4;8.4 Routine pharmacovigilance activities;174
12.2.5;8.5 The need for and selection of additional pharmacovigilance activities;177
12.2.6;8.6 Types of additional pharmacovigilance activities;180
12.2.7;Notes;190
12.2.8;References;190
12.3;9
Assessing the need for risk minimisation;196
12.3.1;9.1 Why evaluating the need for risk minimisation is important;196
12.3.2;9.2 Medication errors are a major source of risk;200
12.3.3;9.3 Evaluation of need for risk minimisation within EU-RMPs and REMS;201
12.3.4;9.4 A multistep approach to evaluate the need for risk minimisation;203
12.3.5;9.5 Alternative techniques for evaluating the need for risk minimisation;219
12.3.6;Notes;224
12.3.7;References;224
12.4;10
Developing risk minimisation plans/risk mitigation strategies ;228
12.4.1;10.1 Overview of risk minimisation;228
12.4.2;10.2 Risk minimisation plan content in EU-RMPs and REMS;231
12.4.3;10.3 Optimising routine risk minimisation measures;232
12.4.4;10.4 Risk minimisation tool options;237
12.4.5;10.5 A multistep approach to select appropriate risk minimisation tools;247
12.4.6;10.6 Factors to consider when designing a risk minimisation programme;254
12.4.7;Notes;267
12.4.8;References;268
13;Part 3 Implementation of risk management plans;272
13.1;11
Evaluating the effectiveness of risk minimisation;274
13.1.1;11.1 Requirements for the assessment of risk minimisation;274
13.1.2;11.2 Developing a risk minimisation evaluation;277
13.1.3;11.3 Selecting appropriate methods for a highquality evaluation;287
13.1.4;11.4 Established and innovative evaluation techniques;295
13.1.5;11.5 Consequences of risk minimisation effectiveness evaluation;303
13.1.6;11.6 Effectiveness evaluation challenges;304
13.1.7;References;305
13.2;12
Implementing risk management activities;310
13.2.1;12.1 Overview of risk management implementation;310
13.2.2;12.2 Configuring companies for effective risk management;312
13.2.3;12.3 Developing a risk management plan document;317
13.2.4;12.4 Implementing pharmacovigilance activities;321
13.2.5;12.5 Implementing risk minimisation activities;322
13.2.6;12.6 Risk management lifecycle activities;335
13.2.7;12.7 Integrating risk management with other activities;336
13.2.8;Note;339
13.2.9;References;339
13.3;13
Effective interactions with health authorities;342
13.3.1;13.1 Overview of regulatory authority interactions;342
13.3.2;13.2 The EU regulatory system for risk management;343
13.3.3;13.3 The US regulatory system for risk management;348
13.3.4;13.4 Optimising interactions between companies and regulators;350
13.3.5;13.5 Preparing for regulatory meetings;351
13.3.6;Notes;354
13.3.7;References;354
14;Part 4 Continuing evolution of risk management;356
14.1;14
Development risk management plans;358
14.1.1;14.1 Role of a development risk management plan (DRMP);358
14.1.2;14.2 Structure and content of a DRMP;360
14.1.3;14.3 Evolution of a DRMP during development;362
14.1.4;14.4 Developmental pharmacovigilance and risk minimisation activities;364
14.1.5;References;367
14.2;15
Benefit–risk assessment and public communication ;368
14.2.1;15.1 Overview of benefit–risk balance
;368
14.2.2;15.2 Challenges for assessment of benefit–risk balance
;370
14.2.3;15.3 Improving benefit–risk evaluation
;377
14.2.4;15.4 Public communication of benefit–risk balance
;382
14.2.5;Notes;387
14.2.6;References;387
14.3;16
The commercial importance of risk management and risksharing schemes;392
14.3.1;16.1 Managing therapeutic and funding risks;392
14.3.2;16.2 Commercial importance of therapeutic risk management;394
14.3.3;16.3 The commercial value of risksharing agreements;396
14.3.4;16.4 Creating added value and synergy in postlaunch programmes;400
14.3.5;References;402
14.4;17
Learnings from other types of risk management ;404
14.4.1;17.1 Other types of risk management in the pharmaceutical industry;404
14.4.2;17.2 Risk management in other industries;407
14.4.3;Note;410
14.4.4;References;410
14.5;18
The outlook for therapeutic risk management;412
14.5.1;18.1 The future of therapeutic risk management;412
14.5.2;References;418
15;Index;420