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OverviewIn recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organisations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report aims primarily to provide a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems.Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled. Full Product DetailsAuthor: Council for International Organizations of Medical SciencesPublisher: Council for International Organizations of Medical Sciences Imprint: Council for International Organizations of Medical Sciences Dimensions: Width: 16.00cm , Height: 0.80cm , Length: 24.00cm Weight: 0.318kg ISBN: 9789290360827ISBN 10: 9290360828 Pages: 143 Publication Date: 05 July 2010 Audience: General/trade , General Format: Paperback Publisher's Status: Active Availability: Awaiting stock  The supplier is currently out of stock of this item. It will be ordered for you and placed on backorder. Once it does come back in stock, we will ship it out for you. Table of ContentsReviewsAuthor InformationCouncil for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. In 2009 CIOMS celebrated the 60th anniversary of its creation.Through its membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. In 2013, the membership of CIOMS included 49 international, national and associate member organizations, representing many of the biomedical disciplines, national academies of sciences and medical research councils. Tab Content 6Author Website:Countries AvailableAll regions |
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