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Post-Market Drug Evaluation Research Training Capacity in Canada: An Environmental Scan of Canadian Educational Institutions

机译:加拿大的上市后药物评估研究培训能力:加拿大教育机构的环境扫描

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Background Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. Objectives The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. Methods A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Results Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. Conclusions As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.
机译:背景技术加拿大卫生部为使药品立法和法规现代化而正在进行的努力将有助于提高药品的安全性和有效性。必须确保有全面而专门的培训场所来培训研究人员以支持治疗产品的监管。目标本教育机构清单的目的是对加拿大的教育机构进行环境扫描,以对学生进行售后药品评估研究领域的培训。方法对加拿大机构进行了基于网络的系统环境扫描。每所大学的网站都经过审查以查找潜在的学术课程。先验确定了六个核心计划领域,以培训合格的上市后药物评估研究人员。这些包括生物统计学,流行病学,药物流行病学,健康经济学或药物经济学,药物遗传学或药物基因组学以及患者安全/药物警戒。结果确定了23所学术机构,它们有潜力在售后药物评估研究中对学生进行培训。总体而言,有23个机构教授了流行病学课程,22个生物统计学课程,17个卫生经济学/药物经济学课程,5个药物流行病学课程,5个药物遗传学/药物基因组学课程和3个患者安全/药物警戒课程。在这23家机构中,只有渥太华大学提供了6门核心课程。两个机构提供了五个,七个提供了四个,其余14个提供了三个或更少。显然,有些机构提供的课程可能未完全反映在本次审核所使用的术语中。结论随着加拿大健康协会朝着更先进的许可框架发展的方向,加强培训以提高药物安全性和有效性研究能力和专业知识是及时和必要的。

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