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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Table of Contents
View the documentINTRODUCTION
View the document1. WHY PHARMACOVIGILANCE?
View the document2. DEFINITION AND AIMS
Open this folder and view contents3. HOW TO START A PHARMACOVIGILANCE CENTRE
Open this folder and view contents4. REPORTING OF ADVERSE DRUG REACTIONS
Open this folder and view contents5. SPECIAL ISSUES IN REPORTING
Open this folder and view contents6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
Open this folder and view contents7. ASSESSMENT OF CASE REPORTS
Open this folder and view contents8. USE OF THE DATA
Open this folder and view contents9. RELATIONS WITH OTHER PARTIES
View the document10. OTHER SOURCES OF INFORMATION
View the document11. FUNDING
View the documentREFERENCES
View the documentGLOSSARY
View the documentCAUSALITY CATEGORIES
View the documentWHO CONTACTS
 

REFERENCES

Stephens MDB. Detection of New Adverse Drug Reactions.
MacMillan Publishers, 1998, ISBN 0-333-693914.

Strom B (Ed). Pharmacoepidemiology (2nd ed).
Wiley, Chichester, 1994. ISBN 0 471 94058 5.

International Drug Monitoring: The Role of National Centres.
WHO Technical Report Series, No. 498, Geneva, 1972.

Rawlins MD. Spontaneous reporting of adverse drug reactions.
Br J Clin Pharmacol 1988; 26:1-11.

Bégaud B, Chaslerie A, Fourrier A, Haramburu F, Miremont G (Eds). Methodological approaches in pharmacoepidemiology. Applications to spontaneous reporting.
Elsevier Science Publishers, Amsterdam, 1993. ISBN 0-444-81-577-5.

Griffin JP, Weber JCP. Voluntary systems of adverse reaction reporting. In: Griffin JP, D’Arcy PF, Harron DWG (Eds). Medicines: Regulation, Research and Risk.
Greystone Books, Antrim, 1989.

Bénichou C (Ed). Adverse drag reactions. A practical guide to diagnosis and management.
Wiley, Chichester, 1994. ISBN 0 471 94211.

Olsson S (Ed). National Pharmacovigilance Systems.
WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden.
2nd ed 1999, ISBN 91-630-7678-0.

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