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.
About the Author: Dr. Anjan "Swapu" Banerjee is Deputy Managing Director and Head of Regulatory and Risk Management Practice at Pope Woodhead & Associates and Faculty Member in Regulatory, Drug safety and Risk Management at the Institute of Biotechnology, Cambridge University, UK. Banerjee has over 15 years' experience in global pharmaceuticals, biotech and devices (clinical development, medical marketing), and more than 30 years' experience in healthcare.
Dr. Stephen Mayall is Senior Consultant at Pope Woodhead & Associates, UK. He has over 13 years of consulting and project management experience within the global pharmaceutical industry, and has been involved in therapeutic risk management since 2003. He has also performed a variety of other consulting projects for global pharmaceutical and biotechnology companies, which have encompassed communications, drug safety, clinical development, regulatory, strategic marketing, market insight and licensing topics.