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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.

• 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

Currently, intensive effort is being directed toward the identification of molecular targets that can provide approaches to the development of novel therapeutic strategies in cancer management. This book focuses on metastasis-associated genes, metastasis promoter and suppressor genes, which relate specifically to behavioral alterations of cancer cells in epithelial mesenchymal transition, cancer stem cell maintenance and propagation, and to the acquisition of invasive and metastasis faculty. The function of these genes has implications for cell cycle regulation and cell proliferation and so constitute an essential element in cancer growth and dissemination. The emphasis in this book is on how appropriate these genes are as molecular targets and how practicable are the constituents of their signal transduction systems as potential candidates and how accessible they are to targeted therapy. Written in a straightforward and clear style with background information supporting the new research, this book will be useful for students and researchers in cancer therapies.

• Identifies molecular targets and their accessibility for therapeutic intervention
• Provides information on biological features of tumor development and dissemination
• Background information provided for each topic

"This is a highly enjoyable and well presented book that I recommend for any clinician from student to experienced practitioner. It is suitable for all physiotherapists, manual therapists, sports physiotherapists/therapists, strength and conditioning coaches, sports scientists, athletes and patients who would like to understand, recover and improve their range and ease of movement."

Jimmy Reynolds, Head of Sports Medicine - Academy, Ipswich Town Football Club, Oct 14