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Risk Management Systems - examples of practical implementation

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Resumo:Purpose To demonstrate the impact of the new legislation of pharmacovigilance in the real-world context by the presentation of practical examples. Methods Critical analysis of the current pharmacovigilance legislation, as well as guidelines and recommendations from the European Medicines Agency (EMA). Results It will be presented a fictitious company risk management system, with its description of the risk management system through the Pharmacovigilance System Master File presentation and a concrete example of a Risk Management Plan of the medicinal product Isotretinoin with detailed implementation proposals of risk minimization measures, in line with the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) for the recent referral procedure of retinoids. Discussion/Conclusions The new European Legislation in Pharmacovigilance and, consequently, the new regulatory requirements have increased the workload and complexity of pharmacovigilance. The focus of the pharmacovigilance system became a proactive, risk proportionate and patient-centered approach, with high level of transparency and engagement of civil society. This approach brings to fulfil previously unmet medical needs and reducing the burden of adverse drugs reactions by promoting the safeguard public health.
Autores principais:Rodrigues, Patrícia de Lurdes Douteiro
Assunto:Pharmacovigilance Legislation Pharmacovigilance System Master File Risk management plan Risk minimization measures PRAC Referral Procedure Isotretinoin Teses de mestrado - 2018
Ano:2018
País:Portugal
Tipo de documento:dissertação de mestrado
Tipo de acesso:acesso aberto
Instituição associada:Universidade de Lisboa
Idioma:inglês
Origem:Repositório da Universidade de Lisboa

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