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
An up-to-date practical guide on conceiving, designing and
implanting global therapeutic risk management plans for medicinesA
number of useful frameworks are presented which add impact to RMPs
(Risk Management Plan), together with regional specific information
(EU, US and Japan).Acomprehensive guide for performing risk
management more effectively throughout a product s life-cycle"
Woodhead Publishing Ltd
|Country of origin:
||Woodhead Publishing Series in Biomedicine
Stephen J. Mayall
• Anjan Swapu Banerjee
||Electronic book text
Nursing & ancillary services >
Pharmacy / dispensing
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