Dictionary of Pharmacovigilance

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9780853695165: Dictionary of Pharmacovigilance
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Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognized adverse drug reactions thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use by providing information to users to optimize safe and effective use while monitoring the impact of any action taken. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities. This dictionary contains a list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.

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Pharmacovigilance is the study of the everyday use of medicines to identify previously unrecognised adverse drug reactions, in order to make a risk-benefit assessment. Pharmacovigilance impacts on many specialist areas such as medical practice, pharmacoepidemiology, public health, but is most closely linked to clinical research, development and drug licensing. The terminology used in this area has precise legal and scientific significance, and may vary from country to country. The Dictionary of Pharmacovigilance dispels any confusion, defining over 3100 abbreviations, terms and phrases including: Absolute Risk Increase (ARI), Establishment Inspection Report (EIR), Fetal valproate syndrome, Proportional reporting ratio, Risk characterisation, and Solicited report. The book is written by an experienced pharmacovigilance scientist with a track record in the pharmaceutical industry and also a regulatory authority. The dictionary will be an essential reference for pharmacovigilance, regulatory affairs and MI professionals worldwide, as well as health care practitioners, medical and medical sciences students, and legal advisors in health care. Amer Alghabban is Senior International Clinical Quality Assurance Auditor at Novartis Pharma, Basel, Switzerland.

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Amer Alghabban
Published by Pharmaceutical Press (2004)
ISBN 10: 0853695164 ISBN 13: 9780853695165
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