Pharmacovigilance in pharmaceutical companies: An overview

Journal of Pharmacology and Pharmacotherapeutics

Volumn 4, Issue SUPPL.1, 2013, Pages

  Mammì, Maria ^a   Citraro, Rita ^a   Torcasio, Giovanni ^a   Cusato, Gennaro ^a   Palleria, Caterina ^a   Di Paola, Eugenio ^a  

^a UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

Author keywords

Italy; pharmaceutical companies; pharmacovigilance; regulation

Indexed keywords

DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; GOVERNMENT REGULATION; ITALY; LAW; PUBLIC HEALTH; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT;

EID: 84889596496     PISSN: 0976500X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0976-500X.120945     Document Type: Review

References (9)

1. World Health Organization. The importance of Pharmacovigilance Safety Monitoring of medicinal products. 2002. Available from: http://www.who. int/medicines/areas/quality-safety/safety-efficacy/pharmvigi/en/.
2. Pharmacovigilance: Ensuring the Safe Use of Medicines. WHO Policy Perspectives on Medicines. October 2004; No. 009.
3. European Medicines Agency. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. 1995.
4. European Medicines Agency. Draft guideline on good pharmacovigilance practices: Module VI-Management and reporting of adverse reactions to medicinal products. 2013.
5. Agenzia Italiana del Farmaco. La nuova legislazione di farmacovigilanza. Available from: http://www.agenziafarmaco.gov.it/.
6. Regulation (EU) No 1235/2010 of the European Parliament and of the Councilof 15 December 2010. Official Journal of the European Union. 2010.
7. Directive 2010/84/EU of the European Parliament and of the Councilof 15 December 2010.Official Journal of the European Union. 2010.
8. European Medicines Agency. Risk-management plans. Available from: http://www.ema.europa.eu/ema/.
9. Klepper MJ. The periodic safety update report as a pharmacovigilance tool. Drug Saf. 2004;27(8):569-78.