Full 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. Introduction2. Basic principles of therapeutic risk management3. The evolution of therapeutic risk management4. Risk management in the European Union5. Risk management in the United States6. Overview of risk management around the world7. Developing a safety specification and selecting risks8. Pharmacovigilance planning9. Assessing the need for risk minimisation10. Developing risk minimisation plans/risk mitigation strategies11. Evaluating the effectiveness of risk minimisation12. Implementing risk management activities13. Effective interactions with health authorities14. Development risk management plans15. Benefit-risk assessment and public communication16. The commercial importance of risk management and risk-sharing schemes17. Learnings from other types of risk management18. The outlook for therapeutic risk management
