Main description:

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.

Contents:

1. Introduction
2. Basic principles of therapeutic risk management
3. The evolution of therapeutic risk management
4. Risk management in the European Union
5. Risk management in the United States
6. Overview of risk management around the world
7. Developing a safety specification and selecting risks
8. Pharmacovigilance planning
9. Assessing the need for risk minimisation
10. Developing risk minimisation plans/risk mitigation strategies
11. Evaluating the effectiveness of risk minimisation
12. Implementing risk management activities
13. Effective interactions with health authorities
14. Development risk management plans
15. Benefit-risk assessment and public communication
16. The commercial importance of risk management and risk-sharing schemes
17. Learnings from other types of risk management
18. The outlook for therapeutic risk management