• Refine Query
  • Source
  • Publication year
  • to
  • Language
  • 1
  • Tagged with
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • 1
  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
1

EquivalÃncia farmacÃutica: proposta de manual para a implantaÃÃo e a padronizaÃÃo de centros em conformidade com as normas tÃcnicas e a legislaÃÃo sanitÃria vigentes. / Pharmaceutical equivalence of medicament: a manual for implementation and standardization of centers, according to the actual technical norms and legislation

Maria do Carmo Gomes Pinheiro 22 October 2004 (has links)
CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / Com a implantaÃÃo da polÃtica de incentivo ao medicamento genÃrico, no Brasil, em 1999, os estudos de equivalÃncia farmacÃutica tornaram-se elementos estratÃgicos para a sua implementaÃÃo e seu Ãxito. Para a realizaÃÃo desses estudos, foi criada uma rede de laboratÃrios, habilitados e supervisionados pela AgÃncia Nacional de VigilÃncia SanitÃria, sob a denominaÃÃo de centros de equivalÃncia farmacÃutica (EQFAR), que passaram a integrar a Rede Brasileira de LaboratÃrios AnalÃticos em SaÃde (Reblas). Os critÃrios para a habilitaÃÃo e operaÃÃo dos centros, bem como para a realizaÃÃo, de maneira padronizada, dos estudos de equivalÃncia farmacÃutica, foram definidos por meio de um conjunto de regulamentos (leis, resoluÃÃes e normas tÃcnicas) cuja abrangÃncia, variedade e extensÃo nem sempre facilitam seu conhecimento, compreensÃo e aplicaÃÃo correta, tanto por parte dos interessados na implantaÃÃo desses centros como dos agentes de vigilÃncia sanitÃria no seu trabalho de avaliaÃÃo, habilitaÃÃo e fiscalizaÃÃo dos Centos e de coordenaÃÃo da rede. Este material consolida o conteÃdo dos regulamentos em vigor, sistematizando-os segundo os seguintes capÃtulos: documentaÃÃo de referÃncia, pessoal, biosseguranÃa e organizaÃÃo laboratorial, instalaÃÃes e acomodaÃÃes ambientais, sistema da qualidade, equipamentos, materiais de laboratÃrio e os principais ensaios que compÃem os estudos de equivalÃncia farmacÃutica e elaboraÃÃo do certificado analÃtico. Objetiva facilitar, por meio de sua manualizaÃÃo, o acesso dos interessados na implantaÃÃo e operaÃÃo de centros de equivalÃncia farmacÃutica e dos agentes de vigilÃncia sanitÃria à informaÃÃo sistematizada e consolidada sobre a matÃria / In 1999, the policy of generic medicaments was implemented in Brazil, and the availability of pharmaceutical equivalence essays became strategic for its success. A group of laboratories was identified, evaluated and qualified, as a network, by the National Sanitary Surveillance Agency (Anvisa) to perform such studies. These laboratories were named âcenters for pharmaceutical equivalenceâ (EQFAR), and were integrated to The Brazilian Network of Analytical Laboratories on Health (REBLAS). The criteria for qualification and operation of the centers, as well as to perform standardized pharmaceutical equivalence essays, were established by a set of regulations (laws, resolutions and technical rules). The extent, diversity and complexity of these regulations do not always facilitate its knowledge, comprehensive and correct application for people interested in implementation of those rules on the centers as well as the National Sanitary Surveillance Agency tasks of evaluation, qualification and audition. This material consolidate the content of the regulation in force, systematizing them according the following chapters: referential documentation, human resources, biosafety and laboratorial organization, facilities and installations, quality assurance, equipment, materials, and the principals essays that compose the studies of pharmaceutical equivalence and the preparation of their analytical certification. It aims to be a practical instruction â like a manual â that allows the rapid access to the weighty information and to facilitate the work of people interested in implement a center of pharmaceutical equivalence and for those from the Sanitary Surveillance Agencies

Page generated in 0.075 seconds