Therapeutic Risk Management of Medicines

Written By Stephen J. Mayall
Therapeutic Risk Management of Medicines
  • Publsiher : Elsevier
  • Release : 16 April 2014
  • ISBN : 1908818271
  • Pages : 448 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Therapeutic Risk Management of Medicines written by Stephen J. Mayall which was release on 16 April 2014, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: 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

Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
  • Author : Stephen J. Mayall,Anjan Swapu Banerjee
  • Publisher : Elsevier
  • Release Date : 2014-04-16
  • Total pages : 448
  • ISBN : 1908818271
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Summary : 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 ...

Risk Management in Blood Transfusion Medicine

Risk Management in Blood Transfusion Medicine
  • Author : J. Mills Barbeau
  • Publisher : Elsevier Health Sciences
  • Release Date : 2019-01-03
  • Total pages : 180
  • ISBN : 1908818271
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Summary : Get a quick, expert overview of risk management in transfusion medicine from Dr. James Mills Barbeau. This practical resource presents a summary of today’s state-of-the-art techniques for reducing harm during all phases of transfusion practice, including blood collection, testing, processing, clinical assessment, and transfusion. It’s an easy-to-read, one-stop ...

The Perception and Management of Therapeutic Risk

The Perception and Management of Therapeutic Risk
  • Author : Paul Slovic,Centre for Medicines Research
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 32
  • ISBN : 1908818271
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Risk and Consent to Risk in Medicine
  • Author : Ronald David Mann
  • Publisher : Parthenon Publishing
  • Release Date : 1989
  • Total pages : 224
  • ISBN : 1908818271
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The Directory of Hospital Personnel
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 1908818271
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Risk Management

Risk Management
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1985
  • Total pages : 212
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  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1995
  • Total pages : 212
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Multiplicative Ideal Theory in Commutative Algebra

Multiplicative Ideal Theory in Commutative Algebra
  • Author : Bruno Horisberger
  • Publisher : Springer
  • Release Date : 1989
  • Total pages : 210
  • ISBN : 1908818271
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Summary : This volume, a tribute to the work of Robert Gilmer, consists of twenty-four articles authored by his most prominent students and followers. These articles combine surveys of past work by Gilmer and others, recent results which have never before seen print, open problems, and extensive bibliographies. The entire collection provides ...

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DICP
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 212
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1996 The Hospital Phone Book
  • Author : U.S. Directory Service
  • Publisher : Briefings Media
  • Release Date : 1996-02
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  • ISBN : 1908818271
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Forensics and Risk Management in Veterinary Medicine
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1998
  • Total pages : 326
  • ISBN : 1908818271
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Australian Family Physician
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2009
  • Total pages : 212
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EAdoption and the Knowledge Economy
  • Author : Paul M. Cunningham
  • Publisher : Unknown
  • Release Date : 2004
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  • ISBN : 1908818271
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Findex
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2002
  • Total pages : 212
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Rehab Management

Rehab Management
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1993
  • Total pages : 212
  • ISBN : 1908818271
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