Current Challenges in Pharmacovigilance Pragmatic Approaches - Report of Cioms Working Group V |
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| Author:
| Council for International Organizations of Medical Sciences Staff, |
| Series title: | A CIOMS Publication |
| ISBN: | 978-92-9036-074-2 |
| Publication Date: | Jun 2001 |
| Publisher: | World Health Organization
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| Book Format: | Paperback |
| List Price: | USD $36.00 |
Book Description:
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The aim of the CIOMS Working Groups is to recommend best practice that will lead to enhanced public health protection in the area of drug safety by ensuring proper focus on substantive scientific and medical inquiry and by eliminating unnecessary administrative requirements. Working Group V hope their suggestions in the following areas will be widely implemented: classification and handling of individual safety case reports from a variety of traditional as well as new sources; some new...
More DescriptionThe aim of the CIOMS Working Groups is to recommend best practice that will lead to enhanced public health protection in the area of drug safety by ensuring proper focus on substantive scientific and medical inquiry and by eliminating unnecessary administrative requirements. Working Group V hope their suggestions in the following areas will be widely implemented: classification and handling of individual safety case reports from a variety of traditional as well as new sources; some new approaches to case management and regulatory reporting practices; improvements and efficiencies in periodic safety reporting; determination and proper use of population exposure data; a critical overview of worldwide regulations and safety reporting.