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Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
Clinical and Applied Thrombosis/Hemostasis ( IF 2.3 ) Pub Date : 2022-07-17 , DOI: 10.1177/10760296221115112
Thao Doan 1 , Fabio Lievano 1 , Linda Scarazzini 1 , Kate Liebelt 1 , Mark Jaradeh 2 , Bulent Kantarcioglu 2 , Jawed Fareed 2, 3 , W Keith Jones 2
Affiliation  

Pharmacovigilance plays a lifesaving role in the practice of medicine. In 2021, during the Coronavirus Infectious Disease 2019 (COVID-19) pandemic, Loyola University Chicago launched a graduate-level Pharmacovigilance Certificate Program (PV-CERT) and a pre-professional non-graduate Pharmacovigilance Certificate Course (EPEC-PV), to provide students a comprehensive and contemporary understanding of the principles and practices of pharmacovigilance. Formal training in pharmacovigilance through this course provided a structured understanding of how safety data are generated through clinical trials and from real-world evidence as well as the regulatory environment in which data are monitored and interpreted. Pharmacovigilance training is of critical importance, especially during the COVID-19 pandemic, during which several drugs were re-purposed for the management of various stages of COVID-19 without conventional safety data. Moreover, the safety of currently-used vaccines is of concern in some populations. Although anticoagulants and antithrombotic medications are crucial in the management of COVID-19, a clear pharmacovigilance program on their use in this indication is not established. As the century progresses, new diseases and infectious agents will require novel therapies for which the evaluation of benefits versus risks will be as essential as it has been for the current COVID-19 pandemic. As such, the Loyola course and accompanying programs on pharmacovigilance will play a key role in educating the next generation of professionals in pursuing careers in the development of therapies that ultimately improve patient outcomes while maintaining rigorous safety standards.



中文翻译:

在 COVID-19 大流行期间开发和实施在线全球药物警戒证书计划

药物警戒在医学实践中起着拯救生命的作用。2021 年,在 2019 年冠状病毒传染病 (COVID-19) 大流行期间,芝加哥洛约拉大学推出了研究生级别的药物警戒证书课程 (PV-CERT) 和专业的非研究生药物警戒证书课程 (EPEC-PV),以让学生全面了解药物警戒的原则和实践。通过本课程进行的药物警戒正式培训提供了对如何通过临床试验和真实世界证据生成安全数据以及监控和解释数据的监管环境的结构化理解。药物警戒培训至关重要,尤其是在 COVID-19 大流行期间,在此期间,在没有常规安全数据的情况下,几种药物被重新用于管理 COVID-19 的各个阶段。此外,目前使用的疫苗的安全性在某些人群中受到关注。尽管抗凝剂和抗血栓药物在 COVID-19 的管理中至关重要,但尚未建立明确的药物警戒计划来说明它们在该适应症中的应用。随着世纪的发展,新的疾病和传染性病原体将需要新的疗法,对这些疗法的收益与风险的评估将与当前的 COVID-19 大流行一样重要。像这样,

更新日期:2022-07-20
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