Pharmacovigilance ISBN 13: 9780470018033

Pharmacovigilance - Hardcover

9780470018033: Pharmacovigilance
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Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject.  The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . 
  • The editors and contributors are of excellent standing within the pharmacovigilance community
  • The text provides exemplary coverage of all the relevant issues
  • The definitive book on the subject

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From the Back Cover:
Since publication of the first edition of PHARMACOVIGILANCE, relevant concepts have moved forwards very rapidly with the publication by the EMEA of a guidance on risk management, and the publication of three guidance documents by the FDA relating to good pharmacovigilance and pharmacoepidemiology practices, premarketing risk assessment, and the development and use of risk minimisation action plans (RiskMAPs).  These rapid strides forwards have required a new edition of PHARMACOVIGILANCE, for the subject remains an area of ever-increasing research endeavour and activity.

The Editors have built on the success of the first edition by expanding the content to include reporting in Germany and Japan, plus a wider range of organ classes and current topics. Otherwise the book retains its structure and purpose – to be a comprehensive volume on the whole area of Pharmacovigilance.

It would be useful to anyone, medic or scientist, new or highly experienced, working in drug safety and may be even more important to those working in medical affairs where drug safety is just one of the functions with which they are involved ....this would also be an excellent book to read in preparation for the Dip. Pharm. Med. Exam .” Pharmaceutical Physician

About the Author:
Ronald D. Mann, Professor Emeritus, University of Southampton, UK. 

Elizabeth B. Andrews, RTI Health Solutions, Research Triangle Institute, UNC School of Public Health and School of Pharmacy, NC, USA

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