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Regulatory issues on pharmacovigilance in Latin American countries

Universidad Nacional de Córdoba; Universidade Estadual Paulista (Unesp); Universidad de la República; Universidad de Chile; Universidad de Assunción (Network of Centres for Study of Pharmaceutical Law, 2014)

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, ...

Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis

Federal University of Paraná; Universidade Estadual Paulista (Unesp) (2021-01-01)

Introduction: Considering the need for effective postmarketing surveillance of disease-modifying therapies (DMTs) in multiple sclerosis (MS), we analyzed the potential of the spontaneous reports for safety signal detection, ...

Outbreak of Aseptic Meningitis associated with Mass Vaccination with a Urabe-containing Measles-Mumps-Rubella Vaccine

Dourado, Maria In??s Costa; Cunha, Sergio; Teixeira, Maria da Gl??ria Lima Cruz; Farrington, C. Paddy; Melo, Ailton de Souza; Lucena, Rita de C??ssia Saldanha de; Barreto, Mauricio Lima (American Journal of Epidemiology, 2000)

Causes for the underreporting of adverse drug events by health professionals: A systematic review

Universidade Estadual Paulista (UNESP) (2014-01-01)

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed ...

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

Universidade Estadual Paulista (Unesp); Ministerio da Saude Comissao Nacional de Incorporacao de Tecnologias (Universidade de São Paulo (USP), Faculdade de Medicina, 2014-03-01)

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to ...

Segurança sanitária de produtos para saúde

Henriques, Cláudio Maierovitch Pessanha; Verotti, Mariana Pastorello (Agência Nacional de Vigilância Sanitária, 2021)

Surveillance of adverse fetal effects of medications (SAFE-Med): Findings from the International Clearinghouse of Birth Defects Surveillance and Research

Lisi, Alessandra; Botto, Lorenzo D.; Robert-Gnansia, Elisabeth; Castilla, Eduardo E.; Bakker, Marian K.; Bianca, Sebastiano; Cocchi, Guido; Vigan, Caterine de; Dutra, Maria da Graça; Horacek, Jiri; Merlob, Paul; Pierini, Anna; Scarano, Gioacchino; Sipek, Antonin; Yamanaka, Michiko; Mastroiacovo, Pierpaolo (Elsevier, 2017)

Adverse event profile of ChAdOx1 nCoV-19 vaccine (AZD1222) in Brazil: Comparison between Bio-Manguinhos/Fiocruz post-marketing surveillance database and clinical trials

Oliveira, Patricia Mouta Nunes de; Pedro, Renata Saraiva; Lignani, Letícia Kegele; Teixeira, Gabriellen Vitiello; Cordeiro, Catherine Crespo; Pereira, Tainá dos Santos; Ramos, Michael Bernardes; Maia, Maria de Lourdes de Sousa (Fiocruz/Instituto de Tecnologia em Imunobiológicos, 2022)

Vigilância pós-comercialização de produtos para saúde: questões sobre organização, gestão e implantação no Sistema Nacional de Vigilância SanitáriaPost-marketing surveillance of health products: questions about organization, management and implementation in the National Health Surveillance System

Melchior, Stela Candioto (2021)

Registro e tecnovigilância de implantes dentários: panorama atual nos EUA, na União Europeia, no Brasil e sugestões de aprimoramento desses sistemasRegistry and surveillance of dental implants: current panorama in the USA, European Union, Brazil and suggestions for improved systems

Jacomo, Diana Ribeiro do Espirito Santo; Nobre, Patrícia Fernandes da Silva; Maia, Mônica Diuana Calasans; Granjeiro, José Mauro; Delgado, Isabella Fernandes (Instituto Nacional de Controle de Qualidade em Saúde, 2016)

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