Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre: 9. RELATIONS WITH OTHER PARTIES: 9.3 Professional medical and pharmaceutical associations

Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]

Table des matières

	INTRODUCTION
	1. WHY PHARMACOVIGILANCE?
	2. DEFINITION AND AIMS
	3. HOW TO START A PHARMACOVIGILANCE CENTRE
		3.1 Basic steps in setting up a Pharmacovigilance Centre
	4. REPORTING OF ADVERSE DRUG REACTIONS
		4.1 Reporting form
		4.2 Reporting by whom?
		4.3 What to report?
		4.4 Mandatory or voluntary reporting?
	5. SPECIAL ISSUES IN REPORTING
		5.1 Central or decentralised reporting?
		5.2 Stimulation of reporting
		5.3 Under-reporting
	6. PRACTICALITIES IN THE ORGANISATION OF A PHARMACOVIGILANCE CENTRE
		6.1 Staff
		6.2 Useful equipment (includes)
		6.3 Continuity
		6.4 Advisory Committees
		6.5 Information service
		6.6 Communications
		6.7 Poison Control and Drug Information Centres
	7. ASSESSMENT OF CASE REPORTS
		7.1 Data-processing
	8. USE OF THE DATA
		8.1 Hypothesis generation and strengthening
		8.2 Drug regulation
		8.3 Information
		8.4 Education and feedback
		8.5 Limitations regarding the use of the data
	9. RELATIONS WITH OTHER PARTIES
		9.1 The Drug Regulatory Authority
		9.2 Pharmaceutical companies
		9.3 Professional medical and pharmaceutical associations
		9.4 World Health Organization
		9.5 National pharmacovigilance centres
		9.6 Academia
		9.7 Media and consumer organisations
	10. OTHER SOURCES OF INFORMATION
	11. FUNDING
	REFERENCES
	GLOSSARY
	CAUSALITY CATEGORIES
	WHO CONTACTS

9.3 Professional medical and pharmaceutical associations

A pharmacovigilance centre should seek the support of professional medical and pharmaceutical associations. In the case of an emergency, these associations should be informed in good time.