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Desarrollo y aprobacin en 2002 una Gua de BPRC. Estos lineamientos son un conjunto de disposiciones con principios bsicos y las mejores prcticas para el superior desempeo del CECMED, siendo una va para organizar sus procedimientos y alcanzar la efectiva regulacin conforme a tendencias reconocidas. (http://www.cecmed.cu/Docs/RegFarm/ DRA/DispGen/Reg/BPR.pdf.) Las BPRC constituyen una declaracin pblica de los patrones que aplica y su compromiso de seguirlos, porque  las reglas no son solamente para los regulados, sino tambin para los reguladores. Su vigencia fue validada con los indicadores publicados por OMS/OPS con posterioridad. 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IjbZ___PPT9<4 {Construccin de capacidades e intensificacin de la colaboracin Ms de 50 tcnicos se han especializado mediante cursos y otras actividades de capacitacin de OMS/OPS. Participacin de expertos en reuniones de consulta para el desarrollo de lineamientos. Intercambio de experiencias en foros regionales y mundiales, tales como las Conferencias Internacionales de Autoridades Reguladoras de Medicamentos, en cuyas ediciones de 2004 y 2008 fueron expuestas las BPRC. Contribucin al fortalecimiento de otras ANRs Participacin en equipos de evaluacin OMS/OPS a otras ARNs. Revisin de herramientas de evaluacin. Participacin en la Red Reguladora de Vacunas de los Pases en Desarrollo para ensayos clnicos. Colaboracin en materia de capacitacin, cursos y talleres OMS/OPS para Autoridades sobre las funciones bsicas de vacunas. 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Vdrs/downrev.xmlDJ1E&): Hk?9y3 N^$3opa{9XGp;S `w7 RF6& %X-//Xp©B 6硒25=4xSC sv0e[1- PK ! _eedrs/media/image1.gifGIF89a f!, @*[ ! I/v (՗ESȘ^ڭZA> (;PK-!Dl [Content_Types].xmlPK-!1_a :_rels/.relsPK-!|/15drs/shapexml.xmlPK-!~!Udrs/_rels/shapexml.xml.relsPK-! VG drs/downrev.xmlPK- ! _eeH drs/media/image1.gifPK O D<4___PPT9 |Evaluacin con indicadores y bsqueda de mejores prcticas de regulacin. La Gua de BPRC con las prcticas en cada funcin, el SGC certificado y con procesos por funciones y la estructura del centro con funciones unificadas, han contribuido a elevar la eficiencia y capacidad de regulacin. La autoevaluacin sistemtica a partir de herramientas disponibles es una oportunidad de mejora. La evaluacin externa rinde frutos superiores a un entrenamiento, con la ventaja de la participacin colectiva y para todas las funciones. La identificacin de fortalezas/debilidades permite estructurar planes con mejor visin y ordenamiento de prioridades, uso adecuado de los recursos disponibles para la transferencia de conocimientos. El desarrollo de mejores mtodos de regulacin ha propiciado un incremento de la colaboracin, intercambio y confianza mutua entre el CECMED, otras ANRs y OMS/OPS. 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Papel de las ARNs de referencia. Fomentar la transparencia entre las ARNs. Que es transparencia? Reconocimiento de la competencia y el desempeo de las ARNs de referencia de la OPS. 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Enfocar los esfuerzos en el sentido de lograr una mayor accesibilidad a medicamentos de virtudes garantizadas. Medicamentos que curen y no que enfermen. 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