PANDRH Technical Document Nº 5 Pan American Network on Drug Regulatory Harmonization PANDRH Technical Document Nº 5 Technical PANDRH Working Group on Pharmacovigilance Good Pharmacovigilance Good Pharmacovigilance Practices for the Americas Good Pharmacovigilance Practices for the Practices for the Americas ISBN 978-92-75-13160-2 PANDRH Technical Document Nº 5 Pan American Network on Drug Regulatory Harmonization Worki ng Group on Pharmacov iigil ilance Good Pharmacovigilance Practices for the Americas Washington, DC June 2011 PAHO Headquarters Library – Catalogued at the source Pan American Health Organization. “Good Pharmacovigilance Practices for the Americas”. Washington, D.C.: PAHO, © 2011. (PANDRH Technical Document Nº 5). 73 p. ISBN 978-92-75-13160-2 Published in Spanish with the title: “Buenas Prácticas de Farmacovigilancia para las Américas” Published in Portuguese with the title: “Boas práticas de farmacovigilância para as Américas” I Title 1. PHARMACOEPIDEMIOLOGY – legislation and jurisprudence 2. NATIONAL HEALTH SURVEILLANCE SYSTEM 3. PHARMACEUTICAL LEGISLATION – standards 4. DRUG LEGISLATION – economics 5. DRUGS AND NARCOTICS CONTROL 6. HEALTH POLICIES 7. AMERICAS NLM QV 733.DA1 Approved by the V PANDRH Conference in 2008. Validated in 2010. © Pan American Health Organization, 2011 All rights reserved. Requests for this publication should be directed to the Area of Health Systems based on Primary Health Care, Project on Essential Medicines and Technologies, Pan American Health Organization / World Health Organization, 525 23rd St., NW, Washington, D.C., USA [phone: +(202) 974-3483; e-mail: cas-
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