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Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic

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 Pharmacovigilanc...

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Autores principales: Doan, Thao, Lievano, Fabio, Scarazzini, Linda, Liebelt, Kate, Jaradeh, Mark, Kantarcioglu, Bulent, Fareed, Jawed, Jones, W. Keith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9297450/
https://www.ncbi.nlm.nih.gov/pubmed/35848566
http://dx.doi.org/10.1177/10760296221115112
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author Doan, Thao
Lievano, Fabio
Scarazzini, Linda
Liebelt, Kate
Jaradeh, Mark
Kantarcioglu, Bulent
Fareed, Jawed
Jones, W. Keith
author_facet Doan, Thao
Lievano, Fabio
Scarazzini, Linda
Liebelt, Kate
Jaradeh, Mark
Kantarcioglu, Bulent
Fareed, Jawed
Jones, W. Keith
author_sort Doan, Thao
collection PubMed
description 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.
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spelling pubmed-92974502022-07-21 Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic Doan, Thao Lievano, Fabio Scarazzini, Linda Liebelt, Kate Jaradeh, Mark Kantarcioglu, Bulent Fareed, Jawed Jones, W. Keith Clin Appl Thromb Hemost Original Manuscript 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. SAGE Publications 2022-07-17 /pmc/articles/PMC9297450/ /pubmed/35848566 http://dx.doi.org/10.1177/10760296221115112 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Manuscript
Doan, Thao
Lievano, Fabio
Scarazzini, Linda
Liebelt, Kate
Jaradeh, Mark
Kantarcioglu, Bulent
Fareed, Jawed
Jones, W. Keith
Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title_full Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title_fullStr Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title_full_unstemmed Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title_short Development and Implementation of an Online Global Pharmacovigilance Certificate Program During the COVID-19 Pandemic
title_sort development and implementation of an online global pharmacovigilance certificate program during the covid-19 pandemic
topic Original Manuscript
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9297450/
https://www.ncbi.nlm.nih.gov/pubmed/35848566
http://dx.doi.org/10.1177/10760296221115112
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