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Therapeutic Risk Management of Medicines
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Main description:

The legislation has evolved rapidly over the last decade and Therapeutic risk management of medicines is an authoritative, and yet practical, guide on planning, writing, implementing and evaluating risk management plans for medicines globally. Chapters are also included on the historical development, lessons from other industries, the regulatory and health authority perspective and public communication of benefit risk. This topic is of critical importance not only to the pharmaceutical and biotechnology industry, but also prescribers, pharmacists, regulators and healthcare policymakers.


Contents:

Introduction and historical background of risk management plans; EU-RMP (Risk Management Plan); USA REMS (Risk Evaluation and Mitigation Strategies); Safety specification; Pharmacovigilance planning; Assessing the need for risk minimization; Risk minimization tools; Implementation of RMPs and REMS; Evaluation of RMPs and REMS; Developmental risk management plans; Effectively negotiating with the health authorities; Public communication of benefit risk.


PRODUCT DETAILS

ISBN-13: 9781908818270
Publisher: Woodhead Publishing Ltd
Publication date: June, 2013
Pages: 250

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