Overview

In spite of progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines, consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for the pharmaceutical industry and drug regulators. The CIOMS Working Group V generated proposals for pragmatic approaches to dealing with issues such as: classification and handling of individual safety case reports from a variety of sources; new approaches to case management and regulatory practices; improvements and efficiences in the format, content and reporting of periodic safety update reports; and determination and use of populations exposure date. The Group also looked at the state of expedited and periodic clinical safety reporting requirements around the world and made recommendations for enhancing the harmonization steps already made. The volume also deals with unfinished and unresolved issues from previous working groups. Overall the document is a comprehensive treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professions.

Full Product Details

Author:   Council for International Organizations of Medical Sciences
Publisher:   World Health Organization
Imprint:   World Health Organization
Weight:   0.076kg
ISBN:  

9789290360742

ISBN 10:   9290360747
Pages:   381
Publication Date:   01 June 2001
Audience:   College/higher education ,  Professional and scholarly ,  Undergraduate ,  Postgraduate, Research & Scholarly
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

Introduction: background; privacy and the protection of personal health data; overview. Sources of individual case reports: spontaneous reports from persons other than healthcare professionals; literature; the Internet; solicited reports; aspects of clinical trials reports; epidemiology; disease-specific registries and regulatory ADR databases; licensor-licencee interactions. Good case management practices: assessing patient and reportor identifiability; criteria for seriousness; criteria for expectedness; case follow-up approaches; role of narratives. Good summary reporting practices PSURs reconsidered: results of a survey on PSUR workloads; proposals for PSUR content modification; proposals relating to frequency and timing of reporting; miscellaneous proposals for managing PSURS. Determination and use of population exposure data: periodic safety update reports and exposure data sources; technical considerations; spontaneous reporting and patient exposure; real examples of denominator determination and use; patient-exposure and measurments of risk. Clinical safety reporting regulations - an overview: basis for comparison of regulations; current atate of affairs; recommendations; conclusion. Summary of proposals.

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