QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV) TRAINING

Introduction

Background of Qualified Persons for Phamacovigilance Fellowship

Pharmacovigilance legislation and requirements are changing across Africa, mostly in line with developments in ICH countries especially the European Union and the United States of America. Mandatory reporting of individual case safety reports by the pharmaceutical industry is certain to become the rule rather than the exception that it is currently. Furthermore, several countries are demanding that all pharmaceutical companies have Qualified Persons for Pharmacovigilance, similar to what pertains in the European Union through the European Medicines Agency.
The WHO-CC of the African Collaborating Centre for Pharmacovigilance has developed a specific course for would-be QPPVs in collaboration with the Food and Drugs Authority (FDA) of Ghana, the national drug regulatory agency. Starting from May 2015, all marketing authorisation holders (including local manufacturers, wholesalers, importers and the research-based international pharmaceutical companies) would be expected to have at least one QPPV each. The training offered by ACC is a mandatory requirement for anyone seeking designation as a QPPV by the FDA.