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The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products
(2002; 52 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentChapter 1 - Introduction
View the documentChapter 2 - A Short History of Involvement in Drug Safety Monitoring by WHO
View the documentChapter 3 - Partners in Pharmacovigilance
View the documentChapter 4 - Pharmacovigilance in Drug Regulation
View the documentChapter 5 - Pharmacovigilance in Clinical Practice
View the documentChapter 6 - Pharmacovigilance in International Health
View the documentChapter 7 - Conclusion and considerations for the future
View the documentGlossary
View the documentReferences
View the documentBack Cover
 

Preface

The Quality Assurance and Safety: Medicines team in WHO aims to assure the safety of medicines by ensuring reliable and timely exchange of information on drug safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug Monitoring. This team is developing a series of publications on Safety Monitoring of Medicinal Products. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring. The draft was widely circulated and discussed at two informal consultations with international experts in pharmacovigilance. The WHO Department of Essential Drugs and Medicines in Geneva held these consultations. Contributions were made by:

Ms N Arthur, Irish Medicines Board, Dublin, Ireland
Dr A Bentsi-Enchill, Vaccine Assessment and Monitoring, WHO, Geneva
Dr M R Couper, Quality Assurance and Safety: Medicines, WHO, Geneva
Dr P Duclos, Vaccine Assessment and Monitoring, WHO, Geneva
Dr I R Edwards, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Mr T Fushimi, Ministry of Health, Labour and Welfare, Tokyo, Japan
Dr K Hartigan-Go, Makati City, Philippines
Dr P Folb, University of Cape Town, Cape Town, South Africa
Dr N A Kshirsagar, GS Medical College and KEM Hospital, Mumbai, India
Dr J K Lazdins-Helds, Product Research and Development, WHO, Geneva
Dr V Lepahkin, Quality Assurance and Safety: Medicines, WHO, Geneva
Dr Y Maruyama, Traditional Medicine, WHO, Geneva
Dr S Pal, Quality Assurance and Safety: Medicines, WHO, Geneva
Mr S Olsson, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
Dr P Olumese, Roll Back Malaria, WHO, Geneva
Dr L Rägo, Quality Assurance and Safety: Medicines, WHO, Geneva
Mr B Rowsell, Ontario, Canada
Dr J S Schou, Charlottenlund, Denmark
Dr R Soulaymani-Bencheikh, Institut Nationale d’Hygiène, Rabat, Morocco
Dr K Tamiya, Quality Assurance and Safety: Medicines, WHO, Geneva

Special thanks go to Dr U Mehta, University of Cape Town, Cape Town, South Africa, who drafted the text and acted as rapporteur at the consultations. Thanks also to Mr B Hugman for his invaluable help in editing the document.

 

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