32 resultados para Regulatory reforms


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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, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.

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The scenario that outlines this research project is characterized by the centrality of ICT on society and the necessity of having them embedded on education, both face-to-face and distance learning. Amongst the available ICT, the medium radio has been chosen due to its popularity within Brazilian society, as well as its 90 years of initiatives applied on education. Although the radio seems to be historically useful to education, it has been supporting more conservative approaches, such as teaching centred practices, simplytransmitted lessons and assessment based on memorization. On the other hand, Brazilian educational system has been changed since the early 90s, and those reforms brought new challenges to the radio on education, such as training critical listeners, concerned citizens, people with aesthetic sensibility, ethical standards etc. Thus, a systematic assessment of the real educational possibilities of the radio is even more necessary. This research projectaims to retrieve the most prominent educational initiatives using the radio, connecting them to the Brazilian regulatory framework on Education. The methodology consists of desk research and official documents analyses.