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dc.contributor.authorTaylor, Michael Duncan
dc.date.accessioned2010-09-16T19:36:15Z
dc.date.available2010-09-16T19:36:15Z
dc.date.issued2010-09-16
dc.identifier.urihttp://hdl.handle.net/10222/13085
dc.description.abstractThis thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion of the proposed Progressive Licensing model, and Bill C-51-An Act to Amend the Food and Drug Act, raises the concerns with a shift to a system largely based on risk assessment and post-market monitoring (pharmacovigilence).en_US
dc.subjectlawen_US
dc.subjectregulationen_US
dc.subjectdrugen_US
dc.subjectFood and Drug Acten_US
dc.subjectpharmaceuticalen_US
dc.subjectclinical trialen_US
dc.subjectrisken_US
dc.subjectprogressive licensingen_US
dc.subjectclinical trialen_US
dc.subjectC-51en_US
dc.subjectnew drugen_US
dc.titleA BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATIONen_US
dc.date.defence2010-08-30
dc.contributor.departmentFaculty of Lawen_US
dc.contributor.degreeMaster of Lawsen_US
dc.contributor.external-examinerWilliam Layheyen_US
dc.contributor.graduate-coordinatorRichard Devlinen_US
dc.contributor.thesis-readerJocelyn Downieen_US
dc.contributor.thesis-readerMichael Hadskisen_US
dc.contributor.thesis-supervisorJocelyn Downieen_US
dc.contributor.ethics-approvalNot Applicableen_US
dc.contributor.manuscriptsNot Applicableen_US
dc.contributor.copyright-releaseNot Applicableen_US
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