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Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal

Portela, Maria da Conceição Constantino; Sinogas, Carlos; Almeida, Fernando Albuquerque; Baptista-Leite, Ricardo; Castro-Caldas, Alexandre

Introdução: A monitorização da segurança associada aos medicamentos biológicos e biossimilares exige um sistema de informação alinhado com o enquadramento regulamentar. Tendo em conta que podem ocorrer descontinuidades entre a regulamentação europeia, nacional e a respetiva tradução operacional, importa pesquisar e identificar essas lacunas. Material e Métodos: Foi desenvolvida uma análise qualitativa dos supor...


Biologicals and Biosimilars: Gaps in the Pharmacovigilance System in Portugal

Portela, Maria da Conceição Constantino; Sinogas, Carlos; Almeida, Fernando Albuquerque de; Baptista-Leite, Ricardo; Castro-Caldas, Alexandre

Introduction: Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance reg...

Data: 2017   |   Origem: Acta Médica Portuguesa

Que soluções para o financiamento da inovação?

Portela, Maria da Conceição Constantino; Fernandes, Adalberto Campos


Medicines compliance and reimbursement level in Portugal

Portela, Maria da Conceição Constantino; Fernandes, Adalberto Campos

During a severe financial crisis, it is a priority to use scientific evidence to identify factors that enable therapeutic compliance by patients. This study aimed to evaluate a possible association between the number of patients who attended a medical appointment and had medicine prescribed and the number of these same patients who purchased the prescribed medicine and whether the level of reimbursement was a d...


What Solutions for the Financing of Innovation?

Portela, Maria da Conceição Constantino; Fernandes, Adalberto Campos

Keywords: Biomedical Technology; Health Care Rationing; Health Priorities; Resource Allocation.; Palavras-chave: Alocação de Recursos; Prioridades em Saúde; Racionalização de Cuidados de Saúde; Tecnologia Biomédica.

Data: 2015   |   Origem: Acta Médica Portuguesa

Does austerity drives healthcare accessibility?

Portela, Maria da Conceição Constantino; Fernandes, Adalberto Campos

The financial crisis may impact on healthcare systems, and challenge healthcare accessibility by increasing the percentage of patients with unmet medical needs due to the cost, the distance, and waiting lists. In order to analyze if austerity drives healthcare accessibility, we take annual data at country level, for Germany, United Kingdom, Spain, France, Italy, Ireland, Greece, and Portugal, from 2005 to 2011 ...


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