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Axis 3 / Subject 3 - Pharmacovigilance

Pharmacovigilance: goals and resources to be applied


Corinne POUGET, pharmacist, freelance consultant, QUAMED network, specific experience in the field of pharmaceutical regulation at the European Pharmacopoeia (EDQM, manager of the certification service at Eur.Ph. for active pharmaceutical raw materials).

General scheme of the Presentation
  • Reflections on the feasibility and relevance of setting up simple tools for pharmacovigilance.
  • Pharmacovigilance, whose purpose is to monitor the risks of undesirable effects resulting from the use of medicines and products for human use, is often not discussed at any length, or at all, in the context of low and middle income countries. These countries are, however, the countries most at risk of exposure to sub standard medicines. Consequently, it is necessary to set up an effective system to provide alerts for risks and undesirable consequences of such medicines.
Essential questions on which the presentation is based
  • Is it opportune or reasonable to set up pharmacovigilance systems in low and middle income countries?
  • If so, how should this be done?