Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries

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dc.contributorCentro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.authorHartmann, Katharinapt_BR
dc.contributor.authorPagliusi, Soniapt_BR
dc.contributor.authorPrecioso, Alexander Robertopt_BR
dc.identifier.citationHartmann K, Pagliusi S, Precioso AR. Landscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countries. Vaccine. 2020 Jul;38(34):5490-5497. doi:10.1016/j.vaccine.2020.06.016.pt_BR
dc.description.abstractDeveloping Countries’ Vaccine Manufacturers Network was tasked with the strategic goal of seeking solutions, jointly with manufacturers, for enabling the stable, sustainable supply of quality vaccines to developing countries to increase global immunization. As vaccines are given to millions of healthy people, including children, to prevent life-threatening diseases, vaccines must meet high safety standards. Vaccine safety monitoring is of paramount importance to maintain trust in vaccination programs globally. Once a vaccine is licensed and recommended for use, its safety and effectiveness must be monitored during its whole lifecycle, as the safety profile and protective effectiveness may change over time. A well-established safety governance model across the organization with underlying processes for data collection, signal and risk management and communication is essential. A "fit for purpose" pharmacovigilance system may vary as it depends on several factors. However, all vaccine manufacturers strive to achieve a pharmacovigilance system satisfying Good Pharmacovigilance Practices, in compliance with national, international and supranational requirements, as applicable. A landscape analysis, using a questionnaire covering nine pharmacovigilance key areas related to an effective system, was conducted to understand the existing pharmacovigilance structures, practices and expertise of vaccine manufacturers from emerging countries, on an institutional level. 34 of the 43 contacted manufacturers participated voluntarily. The survey results show that all respondents have established vaccine safety capacity, mainly in collecting and handling adverse events following immunization and implementing standardized processes; the survey also shows differences in the maturity of the manufacturers’ pharmacovigilance system, Quality Management System, signal and risk management, and safety governance. The analysis provides a tool for manufacturers to gain a "bird's-eye" view of the structure of pharmacovigilance key areas and the operational dimensions covered by each area, to benchmarking against international expectations, serving as a basis to further strengthen pharmacovigilance systems, to support accelerated global vaccine supply.pt_BR
dc.description.sponsorshipBill & Melinda Gates Foundationpt_BR
dc.rightsOpen Accesspt_BR
dc.titleLandscape analysis of pharmacovigilance and related practices among 34 vaccine manufacturers’ from emerging countriespt_BR
dc.contributor.externalIndependent Consultant¦¦Suíçapt_BR
dc.contributor.externalDeveloping Countries Vaccine Manufactures Network (DCVMN)¦¦Suíçapt_BR
dc.subject.keywordPost-marketing surveillancept_BR
dc.subject.keywordInfectious diseasespt_BR
dc.identifier.citationabntv. 38, n. 34, p. 5490-5497, jul. 2020pt_BR
dc.identifier.citationvancouver2020 Jul;38(34):5490-5497pt_BR
dc.contributor.butantanPrecioso, Alexander Roberto|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilância|:Autor de correspondênciapt_BR
dc.sponsorship.butantanBill & Melinda Gates Foundation¦¦1204379pt_BR
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