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dc.contributor.authorMagazu, Samantha
dc.date.accessioned2014-06-26T04:30:21Z
dc.date.available2014-06-26T04:30:21Z
dc.date.issued2013-12
dc.identifier.othermagazu_samantha_201312_ms
dc.identifier.urihttp://purl.galileo.usg.edu/uga_etd/magazu_samantha_201312_ms
dc.identifier.urihttp://hdl.handle.net/10724/29914
dc.description.abstractPharmacovigilance practices have focused on the reporting of adverse drug reactions to medicinal products. In an increasingly global industry, attempts have been made to harmonize pharmacovigilance practices internationally in order to advance the knowledge of a medicine’s safety profile and to ensure that new information is both identified as quickly as possible and communicated to all those potentially impacted. While pharmacovigilance has evolved in recent years, there still remain areas of disharmony in international practices. This thesis compared the pharmacovigilance legislation in the United States with that of the European Union in order to establish what areas of current legislation were harmonized between the regions. Comparisons were also made between the health authorities’ requirements and the recommendations of international organizations. By establishing where disharmony exists, efforts can more efficiently address strategies to create a pharmacovigilance system that can be implemented internationally, thus promoting the safer use of medicines.
dc.languageeng
dc.publisheruga
dc.rightspublic
dc.subjectPharmacovigilance
dc.subjectDrug safety
dc.subjectHarmonization
dc.titleHarmonized pharmacovigilance practices
dc.title.alternativea pathway to safer pharmaceuticals in a globalized industry
dc.typeThesis
dc.description.degreeMS
dc.description.departmentBioPharma Regulatory Affairs
dc.description.majorPharmacy
dc.description.advisorDavid Mullis
dc.description.committeeDavid Mullis
dc.description.committeeRandall Tackett
dc.description.committeePaul Brooks


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