Pharmacovigilance Regulatory Requirements in Latin America

@article{Hoffmann2012PharmacovigilanceRR,
  title={Pharmacovigilance Regulatory Requirements in Latin America},
  author={Elise Hoffmann and Alice Fouretier and Caroline Vergne and Delphine Bertram},
  journal={Pharmaceutical Medicine},
  year={2012},
  volume={26},
  pages={153-164}
}
Latin American pharmacovigilance systems have developed considerably since the early 1990s and have continued to strengthen. [] Key Result Six countries have also established specific requirements for adverse events related to vaccines. Regarding clinical trials, ten countries have regulations for the immediate reporting of adverse events, and eight of them for periodic reporting.

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